WO2014019626A1 - Diagnostic coating - Google Patents

Diagnostic coating Download PDF

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Publication number
WO2014019626A1
WO2014019626A1 PCT/EP2012/065187 EP2012065187W WO2014019626A1 WO 2014019626 A1 WO2014019626 A1 WO 2014019626A1 EP 2012065187 W EP2012065187 W EP 2012065187W WO 2014019626 A1 WO2014019626 A1 WO 2014019626A1
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WO
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Application
Patent type
Prior art keywords
hearing device
hearing
characterized
ear canal
device according
Prior art date
Application number
PCT/EP2012/065187
Other languages
French (fr)
Inventor
Erdal Karamuk
Original Assignee
Phonak Ag
Priority date (The priority date 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 date listed.)
Filing date
Publication date

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Classifications

    • HELECTRICITY
    • H04ELECTRIC COMMUNICATION TECHNIQUE
    • H04RLOUDSPEAKERS, MICROPHONES, GRAMOPHONE PICK-UPS OR LIKE ACOUSTIC ELECTROMECHANICAL TRANSDUCERS; DEAF-AID SETS; PUBLIC ADDRESS SYSTEMS
    • H04R25/00Deaf-aid sets providing an auditory perception; Electric tinnitus maskers providing an auditory perception
    • H04R25/65Housing parts, e.g. shells, tips or moulds, or their manufacture
    • H04R25/652Ear tips; Ear moulds
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00Detecting, measuring or recording for diagnostic purposes; Identification of persons
    • A61B5/68Arrangements of detecting, measuring or recording means, e.g. sensors, in relation to patient
    • A61B5/6801Arrangements of detecting, measuring or recording means, e.g. sensors, in relation to patient specially adapted to be attached to or worn on the body surface
    • A61B5/6813Specially adapted to be attached to a specific body part
    • A61B5/6814Head
    • A61B5/6815Ear
    • A61B5/6817Ear canal
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B2560/00Constructional details of operational features of apparatus; Accessories for medical measuring apparatus
    • A61B2560/02Operational features
    • A61B2560/0242Operational features adapted to measure environmental factors, e.g. temperature, pollution
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B2562/00Details of sensors; Constructional details of sensor housings or probes; Accessories for sensors
    • A61B2562/02Details of sensors specially adapted for in-vivo measurements
    • A61B2562/029Humidity sensors
    • HELECTRICITY
    • H04ELECTRIC COMMUNICATION TECHNIQUE
    • H04RLOUDSPEAKERS, MICROPHONES, GRAMOPHONE PICK-UPS OR LIKE ACOUSTIC ELECTROMECHANICAL TRANSDUCERS; DEAF-AID SETS; PUBLIC ADDRESS SYSTEMS
    • H04R25/00Deaf-aid sets providing an auditory perception; Electric tinnitus maskers providing an auditory perception
    • H04R25/65Housing parts, e.g. shells, tips or moulds, or their manufacture
    • H04R25/658Manufacture of housing parts

Abstract

The surface of the casing or shell and/or a surface coating of an ear worn part of a hearing device, which is designed to be completely or at least partially inside the ear canal of a human comprises a substance reacting upon changing of environmental conditions in the ear canal, such as pH or moisture, blood or exudate.

Description

Diagnostic Coating

The present invention refers to a hearing device according to the preamble of claim 1, as well as to a method for diagnosing the change of physiological conditions in the ear canal.

The inventive hearing device is a hearing device which is prepared to be at least partially placed into the ear canal of a human. For example a hearing device which is worn behind the ear (BTE) and has a part which is worn inside the ear canal. Such a BTE may be designed to have the receiver placed in the ear canal (RIC) . It may be also be a hearing device which is completely worn inside the ear canal (CIC) , it may be inserted more or less deeply in the ear canal. The inventive hearing device may be a passive or active hearing protection device (HPD) , whereby active hearing protection device may be enabled to be used as communication device.

The most preferred hearing device according to the invention is an extended wear hearing aid, which designed to be placed deep into the ear canal of a patient (~4mm to the tympanic membrane, TM) by a hearing healthcare professional and can remain there for a period of several weeks or even months without the need of taking out the device . If such a device is removed from the ear canal, however, it is necessary for the hearing healthcare professional to assess the state of the ear canal with regard to the presence of pressure marks, hematoma, swelling, high moisture, infections (oitis externa) or other conditions that would make an immediate refit questionable. Thus after every removal of the hearing instrument, the patient has to see his/her audiologist or ENT in order to judge the physiological condition of the ear canal. This limits possible other applications of such a hearing device such as :

• Self-insertion of extended wear hearing instruments -

• Application as extended wear hearing protection

• Application as extended wear tinnitus masker

Currently a fundamental limitation of extended wear hearing instruments like the Lyric device (by Phonak) is the need of insertion by an ENT or an audiologist. Although it is relatively easy for the end user to remove the device after discomfort or device failure, an audiologist needs to be present in order to check the health condition of the ear canal and decide whether the ear is safe for re-fitting.

Exposure to excess moisture can cause several types of skin problems. The most prevalent aquatic dermatosis is a condition known as external otitis, or swimmer's ear. Swimmer' s ear can be extremely uncomfortable and can lead to a chronic disease. The accumulation of moisture is a situation frequently observed in extended wear hearing instruments, if the moisture transport properties of the seals around the electronic module are not sufficient.

The object of the present invention is to provide the possibility for the user to recognize a change of physiological conditions within the ear canal when wearing a hearing instrument in the ear for an extended time period.

The present invention proposes a hearing device according to the wording of claim 1.

It is the basic idea of the current invention to include physiologically sensitive markers for instance in the outer shell of the hearing instrument or within a coating thereof, in order to give the end user a direct visual feedback on the health condition of his ear canal. This will be a fundamental facilitator for self-insertion of extended wear hearing instruments. There are various publications, such as for instance WO2010065048A1 and US2010023912A1, which deal with the issue of self-insertion of extended wear deep-canal hearing instruments.

The application of a functional coating onto the outer shell of a hearing aid has already been discussed in various publications: For instance, WO2007146939A2 describes a sealing retainer which can have a coating that can be antimicrobial, provide additional acoustic damping, provide additional friction/retention, hydrophobicity, delivery of antimicrobial agents.

Furthermore, US7454028 describes a method for e.g. drug delivery, using a textile layer on a custom hearing instrument while the textile is preloaded with the substance to release.

Finally, WO2010096032A1 describes the applications of soft local coatings for improved comfort in deep fitted CICs.

In other words, the prior art is focused on the improved biocompatibility (for instance hypoallergenic coatings), hygiene (for instance antimicrobial coatings) , and the treatment (for instance drug eluding coatings) . But none of these coatings has a diagnostic function. This means that none of the coatings would give any feedback to the end user about the condition of the skin within the ear canal.

It is the concept of the present invention to provide the user of an extended wear hearing instrument with means to assess the physiological condition of his ear canal. This is done by a diagnostic coating on the external of the hearing device. The coating contains substances that will react with a change of color to specific environmental conditions. The coating is applied during manufacturing of the device as it is currently done with the acoustic seals e.g. with a silicone coating containing silver particles to act as an antimicrobial agent (see also WO2007146939 A2 ) . The new coating according to the invention will not only contain e.g. silver particles, but also and/or instead diagnostic particles that will change their color upon for example :

• Change of pH of the ear canal skin

• Excessive moisture in the residual volume of the ear canal

• Contact with blood or exudate

One example of such a coating is a pH-sensitive coating.

The relationship between skin pH and inflammation of the external auditory meatus, resulting in acute or chronic otitis externa, has been suggested. This acidic pH helps to ensure stratum corneum cohesion and integrity. Neutralization or alkalinization of the skin has been shown to disrupt corneodesmosomes in the stratum corneum, causing functional abnormalities and aberrant permeability barrier homeostasis. In addition, previous studies have demonstrated that stratum corneum alkalinization is an important antecedent to bacterial and yeast infections. The normal pH is 4-5, which helps inhibit the growth of microorganisms. However, any time the pH changes from acidic to basic, the ear loses this natural protection.

It is well known, that many substances change their color as a result of pH change. Examples of different substances can be found in table 1.

Figure imgf000007_0001

Table 1: Examples of substances that change color with pH value.

The mode of operation is an e.g. pH-sensitive diagnostic coating, which is explained in the figure as attached, as a possible example.

The extended wear hearing device, as shown in position I within the attached figure and designated with 1, has an original color of for instance yellow, which is stable at slightly acidic pH values up to 5.5. The device can for instance be inserted by the end user (in case of self- insertion) or by an audiologist or EN . After the battery has reached its end of life or due to a device failure (e.g. clogging by cerumen), the device 1 needs to be removed eventually by the end user. Now he can observe for any potential color changes of the seals of the device. If there has been a color change e.g. into blue, as shown at stage III and designated as lb, this is an indication for a potential risk, as the pH value of the ear canal skin has changed into more alkaline (>pH6) . It is thus advisable to see an audiologist or an ENT before refitting the next device. This allows to reduce the risk for infections of the ear canal.

On the other hand, if the device has not changed its color, as shown at stage II, and designated with la, then of course the device is ready for re-fitting by self- insertion .

The color of the device is due to absorption of light by the substance of the hearing device. Such a color or a change of color is more easily to be assessed as for example a colorful appearance of an object due to interference effects at its surface which typically depend on illumination conditions like the angle of incidence of the light. Of course the invention is not at all limited to the application of a pH-sensitive substance such as e.g. a coating. Other examples are given in the above description or can be derived due to physiological diseases, possibly occurring within an ear canal. Furthermore, instead of a coating it is also possible to include such a substance into the outer shell surface of a hearing instrument.

The advantages of the present invention are for instance the reduction of medical complications with the use of extended wear devices. Furthermore, it enables the application of self-insertion for deep canal extended wear devices. Also, it makes an easier diagnosis possible in case of a medical complication with extended wear devices. It broadens the application range of extended wear technology to use cases such as for instance hearing protection or tinnitus-maskers. In other words, the present invention is not at all limited to hearing instruments, but to any kind of devices which will be inserted for instance into an ear canal. Finally, it gives higher confidence to fitters, ENTs and end users to the concept of extended wear hearing instruments.

Claims

Claims
1. Hearing device which is designed to be completely or at least partly worn inside the ear canal of a human, characterized in that the surface of the casing or shell and/or a surface coating of the ear worn part of the device comprises a substance reacting upon changes of environmental conditions in the ear canal.
2. Hearing device according to claim 1, characterized in that the substance changes its color upon changes of environmental conditions.
3. Hearing device according to one of the claims 1 or 2, characterized in that the environmental condition in the ear canal is characterized by a humidity or a pH-value of the environment and the substance is pH- or moisture sensitive .
4. Hearing device according to one of the claims 1 to 3, comprising a substance which changes its color in a pH- range of ~ 4.4-8.0, preferably 4.5-7.0, more preferably 5.2-6.2 .
5. Hearing device according to one of the claims 1 to 4, characterized in that change of the environmental condition in the ear canal is due to a change of physiological conditions within the ear canal and the substance reacts upon changes of physiological conditions within the ear canal .
6. Hearing device according to one of claims 1 - 5 characterized in that the hearing device is an extended wear hearing aid.
7. Hearing device according to one of claims 1 - 5 characterized in that the hearing device is an active hearing protection device.
8. Hearing device according to one of claims 1 - 5 characterized in that the hearing device is a passive hearing protection device.
9. Hearing device according to one of claims 1 - 5 characterized in that the hearing device is an BTE- or RIC- hearing device.
10. Hearing device according to one of claims 1 - 5 characterized in that the hearing device is an BTE- or RIC- hearing device.
PCT/EP2012/065187 2012-08-02 2012-08-02 Diagnostic coating WO2014019626A1 (en)

Priority Applications (1)

Application Number Priority Date Filing Date Title
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Publications (1)

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Country Status (1)

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Citations (10)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2001035817A1 (en) * 1999-11-16 2001-05-25 Ozen Diagnostics Ltd. Method and device for diagnosing an inflammatory process
US20020153192A1 (en) * 2001-04-24 2002-10-24 Falco Robert N. Personal protective devices having an energy activated material
US6485451B1 (en) * 2000-08-02 2002-11-26 Welch Allyn, Inc. Body cavity irrigation system
US20050107131A1 (en) * 2003-11-15 2005-05-19 Igor Abramov Wireless apparatus with detachable element
WO2007146939A2 (en) 2006-06-13 2007-12-21 Insound Medical, Inc. Sealing retainer for extended wear hearing devices
US7454028B2 (en) 2002-07-24 2008-11-18 Phonak Ag In-the-ear hearing device
US20100023912A1 (en) 2008-07-22 2010-01-28 Fujitsu Limited Lead frame design support apparatus and lead frame design support method
WO2010065048A1 (en) 2008-12-04 2010-06-10 Schindler Robert A Insertion device for deep-in-the-canal hearing devices
WO2010096032A1 (en) 2009-02-20 2010-08-26 Siemens Hearing Instruments, Inc. Composite hearing instrument shell
WO2012094426A2 (en) * 2011-01-04 2012-07-12 Schwartz Alan N Gel-based seals and fixation devices and associated systems and methods

Patent Citations (10)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2001035817A1 (en) * 1999-11-16 2001-05-25 Ozen Diagnostics Ltd. Method and device for diagnosing an inflammatory process
US6485451B1 (en) * 2000-08-02 2002-11-26 Welch Allyn, Inc. Body cavity irrigation system
US20020153192A1 (en) * 2001-04-24 2002-10-24 Falco Robert N. Personal protective devices having an energy activated material
US7454028B2 (en) 2002-07-24 2008-11-18 Phonak Ag In-the-ear hearing device
US20050107131A1 (en) * 2003-11-15 2005-05-19 Igor Abramov Wireless apparatus with detachable element
WO2007146939A2 (en) 2006-06-13 2007-12-21 Insound Medical, Inc. Sealing retainer for extended wear hearing devices
US20100023912A1 (en) 2008-07-22 2010-01-28 Fujitsu Limited Lead frame design support apparatus and lead frame design support method
WO2010065048A1 (en) 2008-12-04 2010-06-10 Schindler Robert A Insertion device for deep-in-the-canal hearing devices
WO2010096032A1 (en) 2009-02-20 2010-08-26 Siemens Hearing Instruments, Inc. Composite hearing instrument shell
WO2012094426A2 (en) * 2011-01-04 2012-07-12 Schwartz Alan N Gel-based seals and fixation devices and associated systems and methods

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