CA2137098C - Hearing aid to be worn in the ear and method for its manufacture - Google Patents
Hearing aid to be worn in the ear and method for its manufacture Download PDFInfo
- Publication number
- CA2137098C CA2137098C CA002137098A CA2137098A CA2137098C CA 2137098 C CA2137098 C CA 2137098C CA 002137098 A CA002137098 A CA 002137098A CA 2137098 A CA2137098 A CA 2137098A CA 2137098 C CA2137098 C CA 2137098C
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- CA
- Canada
- Prior art keywords
- hearing aid
- diaphragm
- aid according
- support elements
- frustum
- Prior art date
- Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
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Classifications
-
- H—ELECTRICITY
- H04—ELECTRIC COMMUNICATION TECHNIQUE
- H04R—LOUDSPEAKERS, MICROPHONES, GRAMOPHONE PICK-UPS OR LIKE ACOUSTIC ELECTROMECHANICAL TRANSDUCERS; DEAF-AID SETS; PUBLIC ADDRESS SYSTEMS
- H04R25/00—Deaf-aid sets, i.e. electro-acoustic or electro-mechanical hearing aids; Electric tinnitus maskers providing an auditory perception
- H04R25/02—Deaf-aid sets, i.e. electro-acoustic or electro-mechanical hearing aids; Electric tinnitus maskers providing an auditory perception adapted to be supported entirely by ear
-
- H—ELECTRICITY
- H04—ELECTRIC COMMUNICATION TECHNIQUE
- H04R—LOUDSPEAKERS, MICROPHONES, GRAMOPHONE PICK-UPS OR LIKE ACOUSTIC ELECTROMECHANICAL TRANSDUCERS; DEAF-AID SETS; PUBLIC ADDRESS SYSTEMS
- H04R25/00—Deaf-aid sets, i.e. electro-acoustic or electro-mechanical hearing aids; Electric tinnitus maskers providing an auditory perception
- H04R25/45—Prevention of acoustic reaction, i.e. acoustic oscillatory feedback
- H04R25/456—Prevention of acoustic reaction, i.e. acoustic oscillatory feedback mechanically
-
- H—ELECTRICITY
- H04—ELECTRIC COMMUNICATION TECHNIQUE
- H04R—LOUDSPEAKERS, MICROPHONES, GRAMOPHONE PICK-UPS OR LIKE ACOUSTIC ELECTROMECHANICAL TRANSDUCERS; DEAF-AID SETS; PUBLIC ADDRESS SYSTEMS
- H04R25/00—Deaf-aid sets, i.e. electro-acoustic or electro-mechanical hearing aids; Electric tinnitus maskers providing an auditory perception
- H04R25/65—Housing parts, e.g. shells, tips or moulds, or their manufacture
- H04R25/652—Ear tips; Ear moulds
-
- H—ELECTRICITY
- H04—ELECTRIC COMMUNICATION TECHNIQUE
- H04R—LOUDSPEAKERS, MICROPHONES, GRAMOPHONE PICK-UPS OR LIKE ACOUSTIC ELECTROMECHANICAL TRANSDUCERS; DEAF-AID SETS; PUBLIC ADDRESS SYSTEMS
- H04R25/00—Deaf-aid sets, i.e. electro-acoustic or electro-mechanical hearing aids; Electric tinnitus maskers providing an auditory perception
- H04R25/65—Housing parts, e.g. shells, tips or moulds, or their manufacture
- H04R25/652—Ear tips; Ear moulds
- H04R25/654—Ear wax retarders
-
- H—ELECTRICITY
- H04—ELECTRIC COMMUNICATION TECHNIQUE
- H04R—LOUDSPEAKERS, MICROPHONES, GRAMOPHONE PICK-UPS OR LIKE ACOUSTIC ELECTROMECHANICAL TRANSDUCERS; DEAF-AID SETS; PUBLIC ADDRESS SYSTEMS
- H04R25/00—Deaf-aid sets, i.e. electro-acoustic or electro-mechanical hearing aids; Electric tinnitus maskers providing an auditory perception
- H04R25/65—Housing parts, e.g. shells, tips or moulds, or their manufacture
- H04R25/652—Ear tips; Ear moulds
- H04R25/656—Non-customized, universal ear tips, i.e. ear tips which are not specifically adapted to the size or shape of the ear or ear canal
-
- H—ELECTRICITY
- H04—ELECTRIC COMMUNICATION TECHNIQUE
- H04R—LOUDSPEAKERS, MICROPHONES, GRAMOPHONE PICK-UPS OR LIKE ACOUSTIC ELECTROMECHANICAL TRANSDUCERS; DEAF-AID SETS; PUBLIC ADDRESS SYSTEMS
- H04R25/00—Deaf-aid sets, i.e. electro-acoustic or electro-mechanical hearing aids; Electric tinnitus maskers providing an auditory perception
- H04R25/65—Housing parts, e.g. shells, tips or moulds, or their manufacture
- H04R25/658—Manufacture of housing parts
-
- H—ELECTRICITY
- H04—ELECTRIC COMMUNICATION TECHNIQUE
- H04R—LOUDSPEAKERS, MICROPHONES, GRAMOPHONE PICK-UPS OR LIKE ACOUSTIC ELECTROMECHANICAL TRANSDUCERS; DEAF-AID SETS; PUBLIC ADDRESS SYSTEMS
- H04R2460/00—Details of hearing devices, i.e. of ear- or headphones covered by H04R1/10 or H04R5/033 but not provided for in any of their subgroups, or of hearing aids covered by H04R25/00 but not provided for in any of its subgroups
- H04R2460/11—Aspects relating to vents, e.g. shape, orientation, acoustic properties in ear tips of hearing devices to prevent occlusion
Abstract
The hearing aid according to the invention comprises a skeleton, which comprises an outer support element, an inner support element and a connecting element and on which are arranged at least part of the electronic components of the hearing aid. The two support elements essentially form the end faces (IS,AS) of an irregular frustum.
To the support elements is fixed a microporous diaphragm in such a way that it essentially forms the circumferential surface of the frustum. The microporous diaphragm and the skeleton together form a substantially tubular moulding cavity, in which a shaped member adapted to the individual auditory canal is moulded with a hardening moulding material in the ear of the user. Prior to the moulding process the skeleton can be roughly adapted to the individual auditory canal by a corresponding deformation of the connecting element. The microporous diaphragm is preferably not only gas permeable perpendicular to its main faces but also parallel to these faces, is impermeable for the liquid or paste-like moulding material used for moulding the shaped member, and is preferably also water and oil-repellent at least on the outside of the hearing aid.
To the support elements is fixed a microporous diaphragm in such a way that it essentially forms the circumferential surface of the frustum. The microporous diaphragm and the skeleton together form a substantially tubular moulding cavity, in which a shaped member adapted to the individual auditory canal is moulded with a hardening moulding material in the ear of the user. Prior to the moulding process the skeleton can be roughly adapted to the individual auditory canal by a corresponding deformation of the connecting element. The microporous diaphragm is preferably not only gas permeable perpendicular to its main faces but also parallel to these faces, is impermeable for the liquid or paste-like moulding material used for moulding the shaped member, and is preferably also water and oil-repellent at least on the outside of the hearing aid.
Description
21~?~0~~
P07'~? WA.E - 1 - 21. Oktober 1994 HEARING AID TO BE WORN IN THE EAR
AND METHOD FOR ITS MANUFACTURE
The invention relates to a hearing aid to be worn in the ear and to a method for its manufacture according to the preambles of the corresponding independent claims.
Hearing aids to be worn in the ear normally have a microphone directed towards the outside of the ear, a loudspeaker directed towards the interior of the ear, an amplifying electronics and a replaceable battery for operation, all said electronic components being located in a shaped member, whose shape is to a greater or lesser extent adapted to the shape of the auditory canal and is worn in the latter. In order that the hearing aid can be comfortably worn and in order that the hearing aid can fulfil its function in an optimum manner, various demands are made on the shaped member, which it fulfills to a greater or lesser extent as a function of the construction. These requirements are essentially as follows:
- The shaped member must fit well in the auditory canal, so that it has a good position and is still comfortable.
~~~700$
P0722WA.E - 2 - The shaped member must be easily insertable into and removable from the auditory canal.
- The shaped member must permit a pressure compensation in the auditory canal, despite its good fit.
S - The shaped member must prevent feedback of the sound produced by the loudspeaker to the microphone.
- The shaped member must be skin-compatible, must in particular permit a ventilation of the skin of the auditory canal and must not give rise to the exudation of perspiration and earwax.
- The shaped member must be insensitive to the exudations of the auditory canal and easily cleaned with respect thereto and must in particular protect the electronic components of the hearing aid from such exudations.
Apart from these requirements relating to the function of the hearing aid and its wearing comfort, there are economic requirements to the effect that the shaped member must be easy to manufacture. It could additionally be desirable for economic reasons for the electronic components to be accessibly integrated into the hearing aid, so that they can be replaced.
The above requirements are satisfied to a varying extent by known hearing aids worn in the ear. Some of them will be briefly described and compared with the above list of requirements.
The most frequently used method for the manufacture of hearing aids to be worn in the ear comprises a hearing aid advisor, who simultaneously investigates the hearing weaknesses of the potential user, producing a silicone moulding or casting of the auditory canal, on the basis of which is produced a 213'~~19$
P0722WA.E - 3 transparent, positive model of the auditory canal and in said model is moulded a plastics material polymerizable with the aid of light, which hardens from the outside to the inside up to a given layer thickness. This leads to a hollow shaped member, into which the electronic components of the hearing aid are fitted leaving towards the interior of the ear an opening for the loudspeaker and for a pressure compensating channel. Against the outlet of the auditory canal the shaped member is closed with a cover, which contains an opening for the pressure compensating channel and a separate compartment for a replaceable battery.
The thus manufactured hearing aid has a shaped member with a very good fit, but which covers the skin of the auditory canal without interruption in such a way that there can be no question of a ventilation. This unavoidably leads to increased exudation of perspiration and earwax. The part of the auditory canal left free between the eardrum and the hearing aid is open to the outside through the pressure compensating channel, so that a pressure compensation can take place and moisture can also escape. However, the pressure compensating channel can increase the feedback between the loudspeaker and the microphone.
A further disadvantage of this hearing aid is that the openings to the loudspeaker and the pressure compensating channel can .become easily blocked with earwax. For preventing this these openings can also be covered with a liquid-impermeable, but gas-permeable diaphragm, as proposed in European patent application 310,866 (published 12.4.1989).
The described hearing aid manufacturing method is complicated, because the shaped member must be moulded in several positive-negative stages and ~1370~8 p0722WA.E - 4 -because the manufacturing stages are such that they cannot be performed by the hearing aid advisor. Thus, the manufacturer of the hearing aid must deal with the individual production of user-specific equipment.
In order to simplify the manufacturing methods various proposals have been made . Thus, e. g. according to US Patent 4,962,537, it is proposed that the shaped member be in the form of a double-wall bag of a flexible material, a hardening plastic mass being directly pressed between the two walls when in the users ear. 'This method saves a few steps in the manufacture, but the moulded shaped member must still be reworked, in particular it is necessary to subsequently make openings for a pressure compensating channel and for the loudspeaker and it is doubtful whether this can be done by the hearing aid advisor.
The same applies with respect to the hearing aid according to International patent application W092/03894, whose shaped member is directly moulded in the auditory canal.
The two aforementioned manufacturing methods are admittedly simpler than the first-described method, but do not improve the disadvantages with respect to skin contact and feedback. This also applies with regards to the hearing aid of US Patent 4,834,211, in which the shaped member is constituted by a balloon surrounding the electronic components of the hearing aid and which during each insertion into the ear is inflated with a corresponding pump. With such a hearing aid the skin contact and feedback are not improved and there can be no question of a simple insertion in the ear.
The object of an aspect of the present invention is to provide a hearing aid to be worn in the ear with a shaped member adapted to an individual auditory canal (individualized), which hearing aid is manufacturable in a very simple process, in particular is individualizable in a very simple process, and which hearing aid is $ improved with respect to the wearing comfort compared with known hearing aids. In addition, a method is given according to which the hearing aid can be manufactured and in particular individualized.
Roughly speaking the method according to the invention is as follows. A
general hearing aid, not yet adapted to an individual auditory canal, is mass produced. It has an advantageously limitedly plastically deformable skeleton, which carries the electronic components of the hearing aid and to which is fixed a flexible diaphragm in such a way that the skeleton and the diaphragm form a moulding chamber, which is open towards the outside with a pouring opening. The hearing aid is now individualized (adapted to an individual auditory canal), in that the skeleton is shaped in accordance with the individual auditory canal shape, in that the thus partly individualized hearing aid is positioned in the ear and then the moulding chamber is filled with a hardening plastic mass, the diaphragm being deformed and the resulting shaped member being shaped in accordance with the auditory canal. The skeleton and diaphragm are constructed and fixed to one another in such a way that there is no need for any reworking of the hearing aid individualized by shaping the skeleton and moulding the shaped member.
The material and structure of the diaphragm are such that it is permeable for gases as a result of an extremely fine porosity, but impermeable for liquids, in particular for a liquid or paste-like moulding material, and that it is sufficiently elastic to be applied in fold-free manner to the auditory canal wall on moulding the shaped member. Thanks to the gas permeability of the diaphragm there is no need to take any provision for the controlled exit of the air in the moulding chamber during pouring (such as provision of a pouring and/or venting channel reaching into the moulding chamber or evacuation of the airing chamber before pouring). Using a gas permeable diaphragm it is sufficient to provide a pouring opening onto which e.g. an apparatus for pressing the moulding material into the moulding chamber may be fixed tightly.
So that the diaphragm can fulfil its function on a long term basis, it is in addition advantageously water and oil-repellent.
As diaphragm, extensible plastic membranes are suitable which by elongation or perforation through laser, through mechanical means or through plasma etching are made porous. Further suitable diaphragm materials are woven and knitted materials e.g. from plastic fibers. For an improved wearing comfort the diaphragm may consist of a material which is oil and water repellent (e.g. polytetrafluoroethylene) or the diaphragm may be coated on at least the surface facing the auditory canal with an oil and water-repellent coating. This coating can e.g. be an evaporation coated coating of ParylenTM (Union Carbide Corp. USA) or silane.
According to an aspect of the present invention, there is provided a hearing aid comprising an outer surface in the shape of an irregular conical frustum and adapted to be shaped to the conformation of an individual patient's auditory canal, the hearing aid comprising a skeleton comprising an outer support element forming an outer end face of the frustum, an inner support element forming an inner end face of the frustum and a connecting element interconnecting and maintaining the support elements in spaced relationship, the outer support element comprising a pouring opening;
electronic hearing enhancement components carried at least partly by the skeleton; and a tubular, microporous, elastic diaphragm comprising a material which is permeable to gases, impermeable to liquids and is oil repellent, the diaphragm being attached at opposite ends to the inner and outer support elements and forming an outer 6a surface of the frustum;
the support elements, the connecting element and the diaphragm defining an interior volume within the diaphragm comprising a molding cavity adapted to receive a hardenable material through the pouring opening.
According to another aspect of the present invention, there is provided a hearing aid comprising an outer surface in the shape of an irregular conical frustum conforming to an individual patient's auditory canal and comprising a skeleton comprising an outer support element forming an outer end face of the frustum, an inner support element forming an inner end face of the frustum and a connecting element connecting the support elements, the outer support element comprising an opening therethrough;
electronic hearing enhancement components carried at least partly by the skeleton;
a tubular, microporous, elastic diaphragm comprising a material which is permeable to gases, impermeable to liquids and is oil repellent, the diaphragm being attached at opposite ends to the inner and outer support elements and forming an outer surface of the frustum; and a shaped member molded from a hardenable material and confined within a volume defined by the support elements, the connecting element and the diaphragm.
According to a further aspect of the present invention, there is provided a method of adapting the exterior shape of a hearing aid to the conformation of a wearer's auditory canal comprising providing a hearing aid comprising a skeleton comprising an outer support element forming an outer end face of a generally conical frustum, an inner support element forming an inner end face of the frustum and a connecting element connecting the support elements, the outer support element comprising a pouring opening, electronic hearing enhancement components carried at least partly by the skeleton, and a tubular, microporous, elastic diaphragm comprising a material which is permeable to gases, impermeable to liquids and is oil repellent, the diaphragm being attached at opposite ends to the inner and outer support elements and forming 6b an outer surface of the frustum, the support elements, the connecting element and the diaphragm defining an interior volume comprising a molding cavity adapted to receive a hardenable material through the pouring opening;
positioning the hearing aid in the auditory canal of the wearer, and pressing the hardenable material through the pouring opening into the molding cavity.
The manufacturing method according to the invention and the hearing aid manufactured according to this method are described in greater detail hereinafter relative to exemplified embodiments and the attached drawings, wherein show:
P07'~? WA.E - 1 - 21. Oktober 1994 HEARING AID TO BE WORN IN THE EAR
AND METHOD FOR ITS MANUFACTURE
The invention relates to a hearing aid to be worn in the ear and to a method for its manufacture according to the preambles of the corresponding independent claims.
Hearing aids to be worn in the ear normally have a microphone directed towards the outside of the ear, a loudspeaker directed towards the interior of the ear, an amplifying electronics and a replaceable battery for operation, all said electronic components being located in a shaped member, whose shape is to a greater or lesser extent adapted to the shape of the auditory canal and is worn in the latter. In order that the hearing aid can be comfortably worn and in order that the hearing aid can fulfil its function in an optimum manner, various demands are made on the shaped member, which it fulfills to a greater or lesser extent as a function of the construction. These requirements are essentially as follows:
- The shaped member must fit well in the auditory canal, so that it has a good position and is still comfortable.
~~~700$
P0722WA.E - 2 - The shaped member must be easily insertable into and removable from the auditory canal.
- The shaped member must permit a pressure compensation in the auditory canal, despite its good fit.
S - The shaped member must prevent feedback of the sound produced by the loudspeaker to the microphone.
- The shaped member must be skin-compatible, must in particular permit a ventilation of the skin of the auditory canal and must not give rise to the exudation of perspiration and earwax.
- The shaped member must be insensitive to the exudations of the auditory canal and easily cleaned with respect thereto and must in particular protect the electronic components of the hearing aid from such exudations.
Apart from these requirements relating to the function of the hearing aid and its wearing comfort, there are economic requirements to the effect that the shaped member must be easy to manufacture. It could additionally be desirable for economic reasons for the electronic components to be accessibly integrated into the hearing aid, so that they can be replaced.
The above requirements are satisfied to a varying extent by known hearing aids worn in the ear. Some of them will be briefly described and compared with the above list of requirements.
The most frequently used method for the manufacture of hearing aids to be worn in the ear comprises a hearing aid advisor, who simultaneously investigates the hearing weaknesses of the potential user, producing a silicone moulding or casting of the auditory canal, on the basis of which is produced a 213'~~19$
P0722WA.E - 3 transparent, positive model of the auditory canal and in said model is moulded a plastics material polymerizable with the aid of light, which hardens from the outside to the inside up to a given layer thickness. This leads to a hollow shaped member, into which the electronic components of the hearing aid are fitted leaving towards the interior of the ear an opening for the loudspeaker and for a pressure compensating channel. Against the outlet of the auditory canal the shaped member is closed with a cover, which contains an opening for the pressure compensating channel and a separate compartment for a replaceable battery.
The thus manufactured hearing aid has a shaped member with a very good fit, but which covers the skin of the auditory canal without interruption in such a way that there can be no question of a ventilation. This unavoidably leads to increased exudation of perspiration and earwax. The part of the auditory canal left free between the eardrum and the hearing aid is open to the outside through the pressure compensating channel, so that a pressure compensation can take place and moisture can also escape. However, the pressure compensating channel can increase the feedback between the loudspeaker and the microphone.
A further disadvantage of this hearing aid is that the openings to the loudspeaker and the pressure compensating channel can .become easily blocked with earwax. For preventing this these openings can also be covered with a liquid-impermeable, but gas-permeable diaphragm, as proposed in European patent application 310,866 (published 12.4.1989).
The described hearing aid manufacturing method is complicated, because the shaped member must be moulded in several positive-negative stages and ~1370~8 p0722WA.E - 4 -because the manufacturing stages are such that they cannot be performed by the hearing aid advisor. Thus, the manufacturer of the hearing aid must deal with the individual production of user-specific equipment.
In order to simplify the manufacturing methods various proposals have been made . Thus, e. g. according to US Patent 4,962,537, it is proposed that the shaped member be in the form of a double-wall bag of a flexible material, a hardening plastic mass being directly pressed between the two walls when in the users ear. 'This method saves a few steps in the manufacture, but the moulded shaped member must still be reworked, in particular it is necessary to subsequently make openings for a pressure compensating channel and for the loudspeaker and it is doubtful whether this can be done by the hearing aid advisor.
The same applies with respect to the hearing aid according to International patent application W092/03894, whose shaped member is directly moulded in the auditory canal.
The two aforementioned manufacturing methods are admittedly simpler than the first-described method, but do not improve the disadvantages with respect to skin contact and feedback. This also applies with regards to the hearing aid of US Patent 4,834,211, in which the shaped member is constituted by a balloon surrounding the electronic components of the hearing aid and which during each insertion into the ear is inflated with a corresponding pump. With such a hearing aid the skin contact and feedback are not improved and there can be no question of a simple insertion in the ear.
The object of an aspect of the present invention is to provide a hearing aid to be worn in the ear with a shaped member adapted to an individual auditory canal (individualized), which hearing aid is manufacturable in a very simple process, in particular is individualizable in a very simple process, and which hearing aid is $ improved with respect to the wearing comfort compared with known hearing aids. In addition, a method is given according to which the hearing aid can be manufactured and in particular individualized.
Roughly speaking the method according to the invention is as follows. A
general hearing aid, not yet adapted to an individual auditory canal, is mass produced. It has an advantageously limitedly plastically deformable skeleton, which carries the electronic components of the hearing aid and to which is fixed a flexible diaphragm in such a way that the skeleton and the diaphragm form a moulding chamber, which is open towards the outside with a pouring opening. The hearing aid is now individualized (adapted to an individual auditory canal), in that the skeleton is shaped in accordance with the individual auditory canal shape, in that the thus partly individualized hearing aid is positioned in the ear and then the moulding chamber is filled with a hardening plastic mass, the diaphragm being deformed and the resulting shaped member being shaped in accordance with the auditory canal. The skeleton and diaphragm are constructed and fixed to one another in such a way that there is no need for any reworking of the hearing aid individualized by shaping the skeleton and moulding the shaped member.
The material and structure of the diaphragm are such that it is permeable for gases as a result of an extremely fine porosity, but impermeable for liquids, in particular for a liquid or paste-like moulding material, and that it is sufficiently elastic to be applied in fold-free manner to the auditory canal wall on moulding the shaped member. Thanks to the gas permeability of the diaphragm there is no need to take any provision for the controlled exit of the air in the moulding chamber during pouring (such as provision of a pouring and/or venting channel reaching into the moulding chamber or evacuation of the airing chamber before pouring). Using a gas permeable diaphragm it is sufficient to provide a pouring opening onto which e.g. an apparatus for pressing the moulding material into the moulding chamber may be fixed tightly.
So that the diaphragm can fulfil its function on a long term basis, it is in addition advantageously water and oil-repellent.
As diaphragm, extensible plastic membranes are suitable which by elongation or perforation through laser, through mechanical means or through plasma etching are made porous. Further suitable diaphragm materials are woven and knitted materials e.g. from plastic fibers. For an improved wearing comfort the diaphragm may consist of a material which is oil and water repellent (e.g. polytetrafluoroethylene) or the diaphragm may be coated on at least the surface facing the auditory canal with an oil and water-repellent coating. This coating can e.g. be an evaporation coated coating of ParylenTM (Union Carbide Corp. USA) or silane.
According to an aspect of the present invention, there is provided a hearing aid comprising an outer surface in the shape of an irregular conical frustum and adapted to be shaped to the conformation of an individual patient's auditory canal, the hearing aid comprising a skeleton comprising an outer support element forming an outer end face of the frustum, an inner support element forming an inner end face of the frustum and a connecting element interconnecting and maintaining the support elements in spaced relationship, the outer support element comprising a pouring opening;
electronic hearing enhancement components carried at least partly by the skeleton; and a tubular, microporous, elastic diaphragm comprising a material which is permeable to gases, impermeable to liquids and is oil repellent, the diaphragm being attached at opposite ends to the inner and outer support elements and forming an outer 6a surface of the frustum;
the support elements, the connecting element and the diaphragm defining an interior volume within the diaphragm comprising a molding cavity adapted to receive a hardenable material through the pouring opening.
According to another aspect of the present invention, there is provided a hearing aid comprising an outer surface in the shape of an irregular conical frustum conforming to an individual patient's auditory canal and comprising a skeleton comprising an outer support element forming an outer end face of the frustum, an inner support element forming an inner end face of the frustum and a connecting element connecting the support elements, the outer support element comprising an opening therethrough;
electronic hearing enhancement components carried at least partly by the skeleton;
a tubular, microporous, elastic diaphragm comprising a material which is permeable to gases, impermeable to liquids and is oil repellent, the diaphragm being attached at opposite ends to the inner and outer support elements and forming an outer surface of the frustum; and a shaped member molded from a hardenable material and confined within a volume defined by the support elements, the connecting element and the diaphragm.
According to a further aspect of the present invention, there is provided a method of adapting the exterior shape of a hearing aid to the conformation of a wearer's auditory canal comprising providing a hearing aid comprising a skeleton comprising an outer support element forming an outer end face of a generally conical frustum, an inner support element forming an inner end face of the frustum and a connecting element connecting the support elements, the outer support element comprising a pouring opening, electronic hearing enhancement components carried at least partly by the skeleton, and a tubular, microporous, elastic diaphragm comprising a material which is permeable to gases, impermeable to liquids and is oil repellent, the diaphragm being attached at opposite ends to the inner and outer support elements and forming 6b an outer surface of the frustum, the support elements, the connecting element and the diaphragm defining an interior volume comprising a molding cavity adapted to receive a hardenable material through the pouring opening;
positioning the hearing aid in the auditory canal of the wearer, and pressing the hardenable material through the pouring opening into the molding cavity.
The manufacturing method according to the invention and the hearing aid manufactured according to this method are described in greater detail hereinafter relative to exemplified embodiments and the attached drawings, wherein show:
2~.~7U9~
P0722WA.E - 7 -Fig. 1 a diagram of the most important parts of the hearing aid according to the invention for explaining their functions (section parallel to the auditory canal axis).
S Fig.2 an exemplified embodiment of the individualized hearing aid according to the invention in section parallel to the auditory canal axis.
Figs. 3 and 4 further exemplified embodiments of the hearing aid according to the invention in the general state (immediately prior to moulding the shaped member).
Figs. Sa to Sc different methods for manufacturing a diaphragm bag for the hearing aid according to the invention.
Fig. 1 shows the principle of the hearing aid according to the invention in a highly diagrammatic manner. The hearing aid is already in its individualized state and is shown in section parallel to the auditory canal axis. It is substantially shaped like an irregular frustum with a circumferential surface M, a larger end face AS directed towards the outside in the auditory canal and a smaller end face IS directed towards the inside in the auditory canal.
The hearing aid essentially comprises a shaped member 1, whose shape is adapted to the auditory canal and at least on the circumferential surface M, i.e. where it contacts the auditory canal wall when the aid is being worn, is covered with a microporous diaphragm 2. The hearing aid also has a skeleton, which essentially comprises three parts, namely an outer support element 3, which essentially forms the outer end face AS of the aid, an inner support element 4, which essentially forms the inner end face IS of the aid and a 2.37498 connecting element 5, which interconnects the two support elements 3 and 4.
The connecting element S serves to keep the two support elements 3 and 4 in their reciprocal position prior to the moulding of the shaped member and this roughly corresponds to an auditory canal. The connecting element 5 is advantageously deformable to a limited extent, so that as a first individualizing stage the reciprocal position of the support elements 3 and 4 can be adapted to the individual auditory canal.
The outer support element 3 carries a microphone 31 for which it is provided at the corresponding point with sound passage openings 32. The outer support element 3 also forms a closable battery compartment 33 and carries a pouring or injecting opening 34. The inner support element 4 carries a loudspeaker 41 and is also provided with sound passage openings 42.
The microporous diaphragm 2, which surrounds the shaped member at least on its circumferential surface M, is fixed to the two support elements around the two end faces AS and IS (points X in the drawing). The diaphragm 2 can additionally cover entirely the inner end face IS. It can also partly cover the outer end face, but must leave freely accessible the pouring or injecting opening 34 and the battery compartment 33.
The amplifier electronics (not shown) can either be carried by one of the support elements or by the connecting element. It can also be moulded into the shaped member without any special fastening to the skeleton.
The skeleton is advantageously made from plastic. The microporous diaphragm can be fixed to the support elements, e.g. by welding, bonding or ' ' CA 02137098 2004-03-16 corresponding securing members. Further fastening possibilities will be described in conjunction with figs. 2 to 4.
The general hearing aid, from which is produced the individualized hearing aid diagrammatically shown in fig. 1, differs from the latter in that the shaped member 1 is only present as a still undefined moulding cavity between the support elements and the microporous diaphragm. The microporous diaphragm 2 fixed to the support elements 3 and 4 consequently loosely surrounds the skeleton and forms with the support elements a moulding chamber surrounding in tubular manner the skeleton and which is open to the outside through the pouring opening 34.
The moulding chamber between the diaphragm and the skeleton is filled by a suitable plastics material (moulding material) through the pouring opening 34, the hearing aid being positioned in the auditory canal. During moulding the microporous diaphragm is stretched and positioned without folds on the wall of the auditory canal. The moulding material hardens to form the individualized shaped member 1. The requirements made on the moulding material are that it can easily be poured through the pouring opening and that it rapidly hardens. For an increased wearing comfort, it is advantageous to use a moulding material which is, even in its hardened state, slightly deformable elastically, such that the shaped member is able to adapt to the changing form of the auditory canal on e.g. chewing. Obviously the moulding material has to be skin-compatible.
It has been found that the moulding compound based on vinyl polysiloxane which is more particularly used in dental technology and which is manufactured under the name Imprint by 3M is very suitable for the present ~ _ 'I'rade mark ~~37t1J8 P0722WA.E - 10 -purposes. This two-component moulding material is obtainable in easily handlable twin cartridges with cannulas, which can be directly mounted on the pouring opening 34.
It is obviously also possible to use other moulding materials. Advantageously use is made of those materials, which do not split off low-molecular weight radicals during polymerization. Additives, e.g. small foam bodies or hollow glass balls can be added to the moulding material for improving the characteristics of the shaped member as a sound and vibration absorber.
The manufacture of the hearing aid diagrammatically shown in fig. 1 e.g.
involves the following stages:
- Produce the skeleton, e.g. by injection moulding of a suitable plastic.
- Install loudspeaker 41, microphone 31 and amplifier electronics on the skeleton, electrically interconnect them and connect to the battery compartment 33.
- Surround the skeleton with the microporous diaphragm 2 and fix the latter to the support elements 3 and 4 (points X).
- Adapt the general hearing aid manufactured in the first three stages roughly to an individual auditory canal by corresponding deformation of the skeleton or connecting element 5.
- Position the roughly adapted hearing aid in the auditory canal and produce the shaped member by filling the moulding chamber between the diaphragm and the skeleton.
- Insert the battery.
213?~9~
P0722WA.E - 11 -The stages necessary for individualizing the general hearing aid are the deformation of the skeleton and the moulding of the shaped member. Both stages can easily be performed by the hearing aid advisor, in such a way that the user can take away the hearing aid following one session and the S manufacturer only has to produce general hearing aids.
The exemplified embodiments of the hearing aid according to the invention shown in figs. 2 to 4 differ from one another essentially by a pressure compensating channel, which is or may be absent in the first embodiment, and in that the electronic components are accessible to a varying extent. The principle described relative to fig. l is retained in all the embodiments.
Fig. 2 shows a first exemplified embodiment of the hearing aid according to the invention once again in section parallel to the auditory canal axis. The aid is positioned in an auditory canal, the auditory canal walls being indicated by the lines G. The represented hearing aid is already individualized. It has a skeleton, which in turn comprises an outer support element 3, an inner support element 4 and a connecting element 5 and which carries the electronic components. This skeleton is located in a moulded shaped member 1, whose surface directed towards the auditory canal is ,covered by a baglike microporous diaphragm 2.
The two support elements 3 and 4 are constructed as an inner capsule 4.1 with an inner closing element 4.2 and an outer capsule 3.1 with an outer closing element 3.2, which permit an at least partial accessibility with respect to the electronic components on the individualized hearing aid.
~1~7098 P0722WA.E - 12 -The inner capsule 4.1 houses the loudspeaker 41, which is introduced through its opening before the closing element 4.2 is engaged thereon. In the outer capsule 3.1, advantageously in correspondingly arranged compartments, are housed the microphone 31 in a microphone compartment 31.1 and a battery in a battery compartment 33. The amplifier electronics 6 can also be housed in the outer capsule 3.1. The electrical connections between the electronic components of the hearing aid e.g. run through the deformable connecting element 5.
The pouring opening 34, which opens the moulding chamber to the outside, is e.g. shaped onto the outer capsule 3.1. The openings of the individual compartments of the outer capsule 3.1 and the pouring opening 34 are substantially located in one plane, so that they can be jointly closed by the closing element 3.2. However, it is also possible to provide separate closing elements for the different openings or for certain of the openings to design partial areas of the common closing element 3.2 in such a way that they can be opened and closed, without having to open the entire closing element 3.2.
In fig. 2 the battery compartment 33 is closed with such a partial closing element 33.1 and is therefore very readily accessible to the user.
The bag-like microporous diaphragm 2 has a main opening, whose edge is so fixed around the area in which are located the opening of the outer capsule 3.1 and the pouring opening 34, that the entire skeleton except for the pouring opening 34 and the opening of the outer capsule 3.1 is embraced by the diaphragm 2. The fixing of the microporous diaphragm 2 around the outer capsule is brought about by an outer diaphragm fixing means, which can e.g.
comprise a fixing ring 10 positively arranged around the outer capsule (on the left-hand side of the drawing) or by a corresponding positive design of the marginal areas of the closing element 3.2 (on the right-hand side of the ~~~~d98 P0722WA.E - 13 -drawing). If the microporous diaphragm 2 is fixed by the closing element 3.2 to the outer capsule 3.1, the closing element 3.2 must have for the pouring opening 34 a removable partial area (in the manner shown in the drawing for the battery compartment 33) or at least an opening.
Around the opening of the inner capsule 4.1 the microporous diaphragm 2 is fixed with an inner diaphragm fixing means and, as shown, covers the loudspeaker opening or can have in said area a further opening. The inner diaphragm fixing means is e.g. the perforated, inner closing element 4.2 positively fitting onto the opening of the inner capsule 4.1 which secures the diaphragm 2 around the opening of the capsule 4.1 in such a way that the moulding material cannot enter the opening, which in use mechanically protects part 21 of the diaphragm 2 covering the capsule opening mechanically and which does not constitute an obstacle for the sound of the loudspeaker (sound passage openings).
That part of the opening of the outer capsule 3.1 located above the microphone compartment 31.1 can also be covered with a diaphragm. As shown in fig. 2, it can be in the form of a separate diaphragm portion 22 secured between the closing element 4.2 and the capsule wall, or in such a way that the diaphragm 2 engages in one piece over the said opening and is held in the same way as on the opening of the inner capsule 3.1. The closing element 3.2 is advantageously perforated in the area covering the microphone compartment 3.1.
As stated already, the diaphragm 2 can also be welded or bonded to the capsules or the corresponding closing elements.
The embodiment of the inventive hearing aid according to fig. 2 does not have a pressure compensating channel. However, as a pressure compensation between the innermost part of the auditory canal closed by the hearing aid and the outside is necessary, the embodiment must have a microporous diaphragm which is gas permeable not only from main surface to main surface but also parallel to these main surfaces (laterally).
It has been found that a foamed and stretched PTFE diaphragm manufactured under the name GORE-TEX~by W.L. Gore & Co. GmbH
(D-88011 Putzbrunn near Munich) has the necessary characteristic and is suitable for use. It is a foamed and stretched P'TFE material (polyte-trafluoroethylene), which forms a very fine porous diaphragm. This diaphragm not only has the necessary physical characteristics, but is also very friendly to the skin and body (it can be used as a provisional skin in the case of large-surface wounds).
The GORE-TEX diaphragm is not only gas-permeable at right angles to its surfaces, but also parallel t>;ereto, so that not only can the air displaced during moulding escape through this diaphragm, but it can also serve as a pressure compensating means and for ventilating the auditory canal skin. This effect can be improved in that the diaphragm bas on its side facing the skeleton a coarse, porous intermediate layer, which can be a layer of an .
open-pore foam or a gauze.
During the moulding process and particularly during its final phases when the shaped member already firmly engages on the auditory canal, a pressure compensation takes place through the diaphragm and the intermediate layer, ~ _ 'I'rade-mark ~:~~~098 P0722WA.E - 15 -if provided, parallel to the main faces thereof, so that no pressure can build up through the moulding in the auditory canal closed by the shaped member.
Figs. 3 and 4 show another embodiment of the hearing aid according to the invention. 'The principle once again corresponds to that described in conjunction with fig. 1 and the main components of the hearing aid also correspond thereto, so that there is no need to give another description thereof. The difference compared with the hearing aids of figs. 1 and 2 is that the connecting element 5 is hollow and serves as a pressure compensating channel, issuing openings 45 and 35 being provided in the inner support element 4 and the outer support element 3. The pouring opening 34 is arranged in the battery compartment 33. The inner end face IS is covered with a separate diaphragm portion 46, the area of the microphone 31 and the outer issuing opening 45 of the pressure compensating channel also being covered with a separate diaphragm portion 36. The moulding compound is moulded directly around the microphone 31 and the loudspeaker 41 or they can be surrounded on the shaped member side with a sound insulating material 37.
For the embodiment of the inventive hearing aid according to Figs. 3 and 4, which has a pressure compensating channel, it is sufficient, when the microporous diaphragm is gas permeable between its two main faces. The gas permeability in this case is used only for venting the moulding chamber during moulding, whilst the aeration and pressure compensation of the closed part of the auditory canal is taken over by the pressure compensation channel. Such microporous diaphragms are made e.g. from silicone polymers cross-linked by addition or condensation, e.g. from Vinylpolysiloxane, or from other plastic materials. Such originally gas tight membranes are extensible up to 200% and are made porous by laser, by plasma etching or by mechanical means before 2137~9~
P0722WA.E - 16 -being formed into a bag. The pores have a diameter of SO~.m maximum and it shows that 10 to 20 pores per diaphragm bag are sufficient. As stated before the porous diaphragm can be made oil and water-repellent e.g by coating it in a fluorine containing plasma.
Fig. 3 shows the hearing aid in the general state as supplied by the manufacturer.
Fig. 4 shows the hearing aid in the auditory canal G ready for moulding. In order to keep the pouring opening 34 free, the battery and battery compartment cover are removed. In order to free the issuing openings 35 and 45 of the pressure compensating channel, the separate diaphragm portions 36 and 46 (fig. 3) are removed and to the inner end face IS of the hearing aid is fitted a protective element, secured with a wire 7 through the pressure compensating channel and which not only protects the eardrum during moulding, but is also intended to assist the positioning of the not yet individualized hearing aid in the auditory canal. The protective element 48 is e.g. made from foam. The wire 7 carrying the protective element can additionally serve as an aid for the insertion of the hearing aid into the auditory canal and for the removal thereof.
Prior to moulding, i.e. in the general state of the hearing aid, the microporous diaphragm must akeady have a shape roughly corresponding to the auditory canal, so that it surrounds in fold-free manner the shaped member in the individualized state of the hearing aid. In particular it must be fixable with the minimum of folds or creases around its main opening (outer end face) and round the opening on the inner end face. For this purpose the diaphragm must be present in the form of a bag tapering away from the main opening.
2~~T~~B
Such a diaphragm bag can be produced in numerous different ways, as shown in figs. Sa to Sc.
In the case of adequate diaphragm deformability such a bag S, as shown in fig. Sa, can be drawn from a flat portion ME of a diaphragm. This production procedure requires an adequate deformability of the diaphragm, but is advantageous if the inner end face of the hearing aid is to be covered by the diaphragm, i.e. if the diaphragm bag is only to have a main opening, but no further opening.
Fig. Sb shows a method for the manufacture of a diaphragm bag S from a flat diaphragm portion ME, from which has been cut a piece K in the form of a developed frustum jacket. This piece K is formed into the diaphragm bag S
with a main opening H and a further opening W, e.g. by welding.
Fig. Sc shows the manufacture of a diaphragm bag with a main opening H
and a further opening W from a piece of diaphragm hose MS by widening its one end to a larger diameter.
In order to assist the gas exchange in the direction of the main faces of the diaphragm it is possible, as stated, to draw it onto a second layer (intermediate layer), which is located between the diaphragm and the shaped member on the finished hearing aid, i.e. does not come into contact with the skin of the auditory canal. As stated, said layer can be an open-pore foam or a gauze onto which the diaphragm is drawn. It has been found that such an intermediate layer can also facilitate the manufacture of the diaphragm bag.
~~~7oos P0722WA.E - 18 -Figs. 1 to 4 show hearing aids of which the narrower end is worn in the auditory canal while the wider end is positioned in the external ear. It is therefore a so called ITC hearing aid (in the canal). Obviously the inventive hearing aid is adaptable also to be a CIC hearing aid (completely in the canal), which is a hearing aid with a more cylindrical form which is fully inserted into the auditory canal
P0722WA.E - 7 -Fig. 1 a diagram of the most important parts of the hearing aid according to the invention for explaining their functions (section parallel to the auditory canal axis).
S Fig.2 an exemplified embodiment of the individualized hearing aid according to the invention in section parallel to the auditory canal axis.
Figs. 3 and 4 further exemplified embodiments of the hearing aid according to the invention in the general state (immediately prior to moulding the shaped member).
Figs. Sa to Sc different methods for manufacturing a diaphragm bag for the hearing aid according to the invention.
Fig. 1 shows the principle of the hearing aid according to the invention in a highly diagrammatic manner. The hearing aid is already in its individualized state and is shown in section parallel to the auditory canal axis. It is substantially shaped like an irregular frustum with a circumferential surface M, a larger end face AS directed towards the outside in the auditory canal and a smaller end face IS directed towards the inside in the auditory canal.
The hearing aid essentially comprises a shaped member 1, whose shape is adapted to the auditory canal and at least on the circumferential surface M, i.e. where it contacts the auditory canal wall when the aid is being worn, is covered with a microporous diaphragm 2. The hearing aid also has a skeleton, which essentially comprises three parts, namely an outer support element 3, which essentially forms the outer end face AS of the aid, an inner support element 4, which essentially forms the inner end face IS of the aid and a 2.37498 connecting element 5, which interconnects the two support elements 3 and 4.
The connecting element S serves to keep the two support elements 3 and 4 in their reciprocal position prior to the moulding of the shaped member and this roughly corresponds to an auditory canal. The connecting element 5 is advantageously deformable to a limited extent, so that as a first individualizing stage the reciprocal position of the support elements 3 and 4 can be adapted to the individual auditory canal.
The outer support element 3 carries a microphone 31 for which it is provided at the corresponding point with sound passage openings 32. The outer support element 3 also forms a closable battery compartment 33 and carries a pouring or injecting opening 34. The inner support element 4 carries a loudspeaker 41 and is also provided with sound passage openings 42.
The microporous diaphragm 2, which surrounds the shaped member at least on its circumferential surface M, is fixed to the two support elements around the two end faces AS and IS (points X in the drawing). The diaphragm 2 can additionally cover entirely the inner end face IS. It can also partly cover the outer end face, but must leave freely accessible the pouring or injecting opening 34 and the battery compartment 33.
The amplifier electronics (not shown) can either be carried by one of the support elements or by the connecting element. It can also be moulded into the shaped member without any special fastening to the skeleton.
The skeleton is advantageously made from plastic. The microporous diaphragm can be fixed to the support elements, e.g. by welding, bonding or ' ' CA 02137098 2004-03-16 corresponding securing members. Further fastening possibilities will be described in conjunction with figs. 2 to 4.
The general hearing aid, from which is produced the individualized hearing aid diagrammatically shown in fig. 1, differs from the latter in that the shaped member 1 is only present as a still undefined moulding cavity between the support elements and the microporous diaphragm. The microporous diaphragm 2 fixed to the support elements 3 and 4 consequently loosely surrounds the skeleton and forms with the support elements a moulding chamber surrounding in tubular manner the skeleton and which is open to the outside through the pouring opening 34.
The moulding chamber between the diaphragm and the skeleton is filled by a suitable plastics material (moulding material) through the pouring opening 34, the hearing aid being positioned in the auditory canal. During moulding the microporous diaphragm is stretched and positioned without folds on the wall of the auditory canal. The moulding material hardens to form the individualized shaped member 1. The requirements made on the moulding material are that it can easily be poured through the pouring opening and that it rapidly hardens. For an increased wearing comfort, it is advantageous to use a moulding material which is, even in its hardened state, slightly deformable elastically, such that the shaped member is able to adapt to the changing form of the auditory canal on e.g. chewing. Obviously the moulding material has to be skin-compatible.
It has been found that the moulding compound based on vinyl polysiloxane which is more particularly used in dental technology and which is manufactured under the name Imprint by 3M is very suitable for the present ~ _ 'I'rade mark ~~37t1J8 P0722WA.E - 10 -purposes. This two-component moulding material is obtainable in easily handlable twin cartridges with cannulas, which can be directly mounted on the pouring opening 34.
It is obviously also possible to use other moulding materials. Advantageously use is made of those materials, which do not split off low-molecular weight radicals during polymerization. Additives, e.g. small foam bodies or hollow glass balls can be added to the moulding material for improving the characteristics of the shaped member as a sound and vibration absorber.
The manufacture of the hearing aid diagrammatically shown in fig. 1 e.g.
involves the following stages:
- Produce the skeleton, e.g. by injection moulding of a suitable plastic.
- Install loudspeaker 41, microphone 31 and amplifier electronics on the skeleton, electrically interconnect them and connect to the battery compartment 33.
- Surround the skeleton with the microporous diaphragm 2 and fix the latter to the support elements 3 and 4 (points X).
- Adapt the general hearing aid manufactured in the first three stages roughly to an individual auditory canal by corresponding deformation of the skeleton or connecting element 5.
- Position the roughly adapted hearing aid in the auditory canal and produce the shaped member by filling the moulding chamber between the diaphragm and the skeleton.
- Insert the battery.
213?~9~
P0722WA.E - 11 -The stages necessary for individualizing the general hearing aid are the deformation of the skeleton and the moulding of the shaped member. Both stages can easily be performed by the hearing aid advisor, in such a way that the user can take away the hearing aid following one session and the S manufacturer only has to produce general hearing aids.
The exemplified embodiments of the hearing aid according to the invention shown in figs. 2 to 4 differ from one another essentially by a pressure compensating channel, which is or may be absent in the first embodiment, and in that the electronic components are accessible to a varying extent. The principle described relative to fig. l is retained in all the embodiments.
Fig. 2 shows a first exemplified embodiment of the hearing aid according to the invention once again in section parallel to the auditory canal axis. The aid is positioned in an auditory canal, the auditory canal walls being indicated by the lines G. The represented hearing aid is already individualized. It has a skeleton, which in turn comprises an outer support element 3, an inner support element 4 and a connecting element 5 and which carries the electronic components. This skeleton is located in a moulded shaped member 1, whose surface directed towards the auditory canal is ,covered by a baglike microporous diaphragm 2.
The two support elements 3 and 4 are constructed as an inner capsule 4.1 with an inner closing element 4.2 and an outer capsule 3.1 with an outer closing element 3.2, which permit an at least partial accessibility with respect to the electronic components on the individualized hearing aid.
~1~7098 P0722WA.E - 12 -The inner capsule 4.1 houses the loudspeaker 41, which is introduced through its opening before the closing element 4.2 is engaged thereon. In the outer capsule 3.1, advantageously in correspondingly arranged compartments, are housed the microphone 31 in a microphone compartment 31.1 and a battery in a battery compartment 33. The amplifier electronics 6 can also be housed in the outer capsule 3.1. The electrical connections between the electronic components of the hearing aid e.g. run through the deformable connecting element 5.
The pouring opening 34, which opens the moulding chamber to the outside, is e.g. shaped onto the outer capsule 3.1. The openings of the individual compartments of the outer capsule 3.1 and the pouring opening 34 are substantially located in one plane, so that they can be jointly closed by the closing element 3.2. However, it is also possible to provide separate closing elements for the different openings or for certain of the openings to design partial areas of the common closing element 3.2 in such a way that they can be opened and closed, without having to open the entire closing element 3.2.
In fig. 2 the battery compartment 33 is closed with such a partial closing element 33.1 and is therefore very readily accessible to the user.
The bag-like microporous diaphragm 2 has a main opening, whose edge is so fixed around the area in which are located the opening of the outer capsule 3.1 and the pouring opening 34, that the entire skeleton except for the pouring opening 34 and the opening of the outer capsule 3.1 is embraced by the diaphragm 2. The fixing of the microporous diaphragm 2 around the outer capsule is brought about by an outer diaphragm fixing means, which can e.g.
comprise a fixing ring 10 positively arranged around the outer capsule (on the left-hand side of the drawing) or by a corresponding positive design of the marginal areas of the closing element 3.2 (on the right-hand side of the ~~~~d98 P0722WA.E - 13 -drawing). If the microporous diaphragm 2 is fixed by the closing element 3.2 to the outer capsule 3.1, the closing element 3.2 must have for the pouring opening 34 a removable partial area (in the manner shown in the drawing for the battery compartment 33) or at least an opening.
Around the opening of the inner capsule 4.1 the microporous diaphragm 2 is fixed with an inner diaphragm fixing means and, as shown, covers the loudspeaker opening or can have in said area a further opening. The inner diaphragm fixing means is e.g. the perforated, inner closing element 4.2 positively fitting onto the opening of the inner capsule 4.1 which secures the diaphragm 2 around the opening of the capsule 4.1 in such a way that the moulding material cannot enter the opening, which in use mechanically protects part 21 of the diaphragm 2 covering the capsule opening mechanically and which does not constitute an obstacle for the sound of the loudspeaker (sound passage openings).
That part of the opening of the outer capsule 3.1 located above the microphone compartment 31.1 can also be covered with a diaphragm. As shown in fig. 2, it can be in the form of a separate diaphragm portion 22 secured between the closing element 4.2 and the capsule wall, or in such a way that the diaphragm 2 engages in one piece over the said opening and is held in the same way as on the opening of the inner capsule 3.1. The closing element 3.2 is advantageously perforated in the area covering the microphone compartment 3.1.
As stated already, the diaphragm 2 can also be welded or bonded to the capsules or the corresponding closing elements.
The embodiment of the inventive hearing aid according to fig. 2 does not have a pressure compensating channel. However, as a pressure compensation between the innermost part of the auditory canal closed by the hearing aid and the outside is necessary, the embodiment must have a microporous diaphragm which is gas permeable not only from main surface to main surface but also parallel to these main surfaces (laterally).
It has been found that a foamed and stretched PTFE diaphragm manufactured under the name GORE-TEX~by W.L. Gore & Co. GmbH
(D-88011 Putzbrunn near Munich) has the necessary characteristic and is suitable for use. It is a foamed and stretched P'TFE material (polyte-trafluoroethylene), which forms a very fine porous diaphragm. This diaphragm not only has the necessary physical characteristics, but is also very friendly to the skin and body (it can be used as a provisional skin in the case of large-surface wounds).
The GORE-TEX diaphragm is not only gas-permeable at right angles to its surfaces, but also parallel t>;ereto, so that not only can the air displaced during moulding escape through this diaphragm, but it can also serve as a pressure compensating means and for ventilating the auditory canal skin. This effect can be improved in that the diaphragm bas on its side facing the skeleton a coarse, porous intermediate layer, which can be a layer of an .
open-pore foam or a gauze.
During the moulding process and particularly during its final phases when the shaped member already firmly engages on the auditory canal, a pressure compensation takes place through the diaphragm and the intermediate layer, ~ _ 'I'rade-mark ~:~~~098 P0722WA.E - 15 -if provided, parallel to the main faces thereof, so that no pressure can build up through the moulding in the auditory canal closed by the shaped member.
Figs. 3 and 4 show another embodiment of the hearing aid according to the invention. 'The principle once again corresponds to that described in conjunction with fig. 1 and the main components of the hearing aid also correspond thereto, so that there is no need to give another description thereof. The difference compared with the hearing aids of figs. 1 and 2 is that the connecting element 5 is hollow and serves as a pressure compensating channel, issuing openings 45 and 35 being provided in the inner support element 4 and the outer support element 3. The pouring opening 34 is arranged in the battery compartment 33. The inner end face IS is covered with a separate diaphragm portion 46, the area of the microphone 31 and the outer issuing opening 45 of the pressure compensating channel also being covered with a separate diaphragm portion 36. The moulding compound is moulded directly around the microphone 31 and the loudspeaker 41 or they can be surrounded on the shaped member side with a sound insulating material 37.
For the embodiment of the inventive hearing aid according to Figs. 3 and 4, which has a pressure compensating channel, it is sufficient, when the microporous diaphragm is gas permeable between its two main faces. The gas permeability in this case is used only for venting the moulding chamber during moulding, whilst the aeration and pressure compensation of the closed part of the auditory canal is taken over by the pressure compensation channel. Such microporous diaphragms are made e.g. from silicone polymers cross-linked by addition or condensation, e.g. from Vinylpolysiloxane, or from other plastic materials. Such originally gas tight membranes are extensible up to 200% and are made porous by laser, by plasma etching or by mechanical means before 2137~9~
P0722WA.E - 16 -being formed into a bag. The pores have a diameter of SO~.m maximum and it shows that 10 to 20 pores per diaphragm bag are sufficient. As stated before the porous diaphragm can be made oil and water-repellent e.g by coating it in a fluorine containing plasma.
Fig. 3 shows the hearing aid in the general state as supplied by the manufacturer.
Fig. 4 shows the hearing aid in the auditory canal G ready for moulding. In order to keep the pouring opening 34 free, the battery and battery compartment cover are removed. In order to free the issuing openings 35 and 45 of the pressure compensating channel, the separate diaphragm portions 36 and 46 (fig. 3) are removed and to the inner end face IS of the hearing aid is fitted a protective element, secured with a wire 7 through the pressure compensating channel and which not only protects the eardrum during moulding, but is also intended to assist the positioning of the not yet individualized hearing aid in the auditory canal. The protective element 48 is e.g. made from foam. The wire 7 carrying the protective element can additionally serve as an aid for the insertion of the hearing aid into the auditory canal and for the removal thereof.
Prior to moulding, i.e. in the general state of the hearing aid, the microporous diaphragm must akeady have a shape roughly corresponding to the auditory canal, so that it surrounds in fold-free manner the shaped member in the individualized state of the hearing aid. In particular it must be fixable with the minimum of folds or creases around its main opening (outer end face) and round the opening on the inner end face. For this purpose the diaphragm must be present in the form of a bag tapering away from the main opening.
2~~T~~B
Such a diaphragm bag can be produced in numerous different ways, as shown in figs. Sa to Sc.
In the case of adequate diaphragm deformability such a bag S, as shown in fig. Sa, can be drawn from a flat portion ME of a diaphragm. This production procedure requires an adequate deformability of the diaphragm, but is advantageous if the inner end face of the hearing aid is to be covered by the diaphragm, i.e. if the diaphragm bag is only to have a main opening, but no further opening.
Fig. Sb shows a method for the manufacture of a diaphragm bag S from a flat diaphragm portion ME, from which has been cut a piece K in the form of a developed frustum jacket. This piece K is formed into the diaphragm bag S
with a main opening H and a further opening W, e.g. by welding.
Fig. Sc shows the manufacture of a diaphragm bag with a main opening H
and a further opening W from a piece of diaphragm hose MS by widening its one end to a larger diameter.
In order to assist the gas exchange in the direction of the main faces of the diaphragm it is possible, as stated, to draw it onto a second layer (intermediate layer), which is located between the diaphragm and the shaped member on the finished hearing aid, i.e. does not come into contact with the skin of the auditory canal. As stated, said layer can be an open-pore foam or a gauze onto which the diaphragm is drawn. It has been found that such an intermediate layer can also facilitate the manufacture of the diaphragm bag.
~~~7oos P0722WA.E - 18 -Figs. 1 to 4 show hearing aids of which the narrower end is worn in the auditory canal while the wider end is positioned in the external ear. It is therefore a so called ITC hearing aid (in the canal). Obviously the inventive hearing aid is adaptable also to be a CIC hearing aid (completely in the canal), which is a hearing aid with a more cylindrical form which is fully inserted into the auditory canal
Claims (26)
1. A hearing aid comprising an outer surface in the shape of an irregular conical frustum and adapted to be shaped to the conformation of an individual patient's auditory canal, the hearing aid comprising a skeleton comprising an outer support element forming an outer end face of the frustum, an inner support element forming an inner end face of said frustum and a connecting element interconnecting and maintaining said support elements in spaced relationship, said outer support element comprising a pouring opening;
electronic hearing enhancement components carried at least partly by said skeleton; and a tubular, microporous, elastic diaphragm comprising a material which is permeable to gases, impermeable to liquids and is oil repellent, said diaphragm being attached at opposite ends to said inner and outer support elements and forming an outer surface of said frustum;
said support elements, said connecting element and said diaphragm defining an interior volume within said diaphragm comprising a molding cavity adapted to receive a hardenable material through said pouring opening.
electronic hearing enhancement components carried at least partly by said skeleton; and a tubular, microporous, elastic diaphragm comprising a material which is permeable to gases, impermeable to liquids and is oil repellent, said diaphragm being attached at opposite ends to said inner and outer support elements and forming an outer surface of said frustum;
said support elements, said connecting element and said diaphragm defining an interior volume within said diaphragm comprising a molding cavity adapted to receive a hardenable material through said pouring opening.
2. The hearing aid according to claim 1 wherein said material of said diaphragm is foamed and stretched polytetrafluoroethylene.
3. The hearing aid according to claim 2 further comprising an intermediate layer on an inner surface of said diaphragm.
4. The hearing aid according to claim 3 wherein said intermediate layer comprises an open-pore foam or a gauze.
5. The hearing aid according to claim 1 wherein said material of said diaphragm is woven or knitted from plastic fibers and is coated on at least one side with a water-and oil-repellent coating.
6. The hearing aid according to claim 5 further comprising an intermediate layer on an inner surface of said diaphragm.
7. The hearing aid according to claim 6 wherein said intermediate layer comprises a open-pore foam or a gauze.
8. The hearing aid according to claim 1 wherein at least one of said inner and outer support elements comprises a capsule with a closing element.
9. The hearing aid according to claim 1 wherein said diaphragm is attached to said support elements by welding, bonding or a mechanical attachment means.
10. The hearing aid according to claim 9 wherein said connecting element is plastically deformable.
11. The hearing aid according to claim 1 wherein said connecting element has a hollow interior volume and said inner and outer support elements comprise openings communicating with said interior volume, whereby said connecting element and said support elements form a pressure compensating channel.
12. A hearing aid comprising an outer surface in the shape of an irregular conical frustum conforming to an individual patient's auditory canal and comprising a skeleton comprising an outer support element forming an outer end face of the frustum, an inner support element forming an inner end face of said frustum and a connecting element connecting said support elements, said outer support element comprising an opening therethrough;
electronic hearing enhancement components carried at least partly by said skeleton;
a tubular, microporous, elastic diaphragm comprising a material which is permeable to gases, impermeable to liquids and is oil repellent, said diaphragm being attached at opposite ends to said inner and outer support elements and forming an outer surface of said frustum; and a shaped member molded from a hardenable material and confined within a volume defined by said support elements, said connecting element and said diaphragm.
electronic hearing enhancement components carried at least partly by said skeleton;
a tubular, microporous, elastic diaphragm comprising a material which is permeable to gases, impermeable to liquids and is oil repellent, said diaphragm being attached at opposite ends to said inner and outer support elements and forming an outer surface of said frustum; and a shaped member molded from a hardenable material and confined within a volume defined by said support elements, said connecting element and said diaphragm.
13. The hearing aid according to claim 12 wherein said shaped member comprises vinyl polysiloxane.
14. The hearing aid according to claim 12 wherein said shaped member comprises an additive for improving absorbing characteristics.
15. The hearing aid according to claim 14 wherein said additive is selected from the group consisting of foam pieces, hollow glass and plastic balls.
16. The hearing aid according to claim 12 wherein at least one of said end faces is at least partly covered by said diaphragm.
17. The hearing aid according to claim 12 wherein said material of said diaphragm is foamed and stretched polytetrafluoroethylene.
18. The hearing aid according to claim 12 further comprising an intermediate layer on an inner surface of said diaphragm.
19. The hearing aid according to claim 18 wherein said intermediate layer comprises a open-pore foam or a gauze.
20. The hearing aid according to claim 12 wherein said material of said diaphragm is woven or knitted from plastic fibers and is coated on at least one side with a water-and oil-repellent coating.
21. The hearing aid according to claim 20 further comprising an intermediate layer on an inner surface of said diaphragm.
22. The hearing aid according to claim 21 wherein said intermediate layer comprises a open-pore foam or a gauze.
23. The hearing aid according to claim 12 wherein at least one of said inner and outer support elements comprises a capsule with a closing element.
24. The hearing aid according to claim 12 wherein said diaphragm is attached to said support elements by welding, bonding or a mechanical attachment means.
25. A method of adapting the exterior shape of a hearing aid to the conformation of a wearer's auditory canal comprising;
providing a hearing aid comprising a skeleton comprising an outer support element forming an outer end face of a generally conical frustum, an inner support element forming an inner end face of said frustum and a connecting element connecting said support elements, said outer support element comprising a pouring opening, electronic hearing enhancement components carried at least partly by said skeleton, and a tubular, microporous, elastic diaphragm comprising a material which is permeable to gases, impermeable to liquids and is oil repellent, said diaphragm being attached at opposite ends to said inner and outer support elements and forming an outer surface of said frustum, said support elements, said connecting element and said diaphragm defining an interior volume comprising a molding cavity adapted to receive a hardenable material through said pouring opening;
positioning the hearing aid in the auditory canal of the wearer; and pressing the hardenable material through the pouring opening into the molding cavity.
providing a hearing aid comprising a skeleton comprising an outer support element forming an outer end face of a generally conical frustum, an inner support element forming an inner end face of said frustum and a connecting element connecting said support elements, said outer support element comprising a pouring opening, electronic hearing enhancement components carried at least partly by said skeleton, and a tubular, microporous, elastic diaphragm comprising a material which is permeable to gases, impermeable to liquids and is oil repellent, said diaphragm being attached at opposite ends to said inner and outer support elements and forming an outer surface of said frustum, said support elements, said connecting element and said diaphragm defining an interior volume comprising a molding cavity adapted to receive a hardenable material through said pouring opening;
positioning the hearing aid in the auditory canal of the wearer; and pressing the hardenable material through the pouring opening into the molding cavity.
26. The method according to claim 25 comprising, before the step of pressing the hardenable material, shaping the skeleton approximately to the shape of the auditory canal.
Priority Applications (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CA002137098A CA2137098C (en) | 1994-12-01 | 1994-12-01 | Hearing aid to be worn in the ear and method for its manufacture |
Applications Claiming Priority (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CA002137098A CA2137098C (en) | 1994-12-01 | 1994-12-01 | Hearing aid to be worn in the ear and method for its manufacture |
Publications (2)
| Publication Number | Publication Date |
|---|---|
| CA2137098A1 CA2137098A1 (en) | 1996-06-02 |
| CA2137098C true CA2137098C (en) | 2004-10-26 |
Family
ID=4154779
Family Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| CA002137098A Expired - Fee Related CA2137098C (en) | 1994-12-01 | 1994-12-01 | Hearing aid to be worn in the ear and method for its manufacture |
Country Status (1)
| Country | Link |
|---|---|
| CA (1) | CA2137098C (en) |
-
1994
- 1994-12-01 CA CA002137098A patent/CA2137098C/en not_active Expired - Fee Related
Also Published As
| Publication number | Publication date |
|---|---|
| CA2137098A1 (en) | 1996-06-02 |
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Legal Events
| Date | Code | Title | Description |
|---|---|---|---|
| EEER | Examination request | ||
| MKLA | Lapsed |
Effective date: 20141201 |