WO2019220336A1

WO2019220336A1 - System for programming cochlear implants and hearing aids based on the detection of the stapedial reflex

Info

Publication number: WO2019220336A1
Application number: PCT/IB2019/053982
Authority: WO
Inventors: Claudio PAGANELLI
Original assignee: Horentek S.R.L.
Priority date: 2018-05-15
Filing date: 2019-05-14
Publication date: 2019-11-21
Also published as: IT201800005398A1

Abstract

The present patent application refers to a system (100) for the detection of the stapedial reflex in a patient wearing a cochlear implant (60) or a hearing aid, when such patient undergoes an external stimulation of the cochlear implant or to the hearing aid, as well as a method for detecting the stapedial reflex which can be implemented by means of such system (100). The system (100) comprises: - a probe (30) apt to be inserted in the ear (20) of the patient, comprising an emitting source (31) configured to emit a probe tone (31') in such a way as to generate an acoustic pressure reflected from the tympanic membrane following the contraction of the stapedius muscle of the ear (20), and at least one microphone unit (35) apt to detect in continuous mode, an acoustic pressure reflected (35') from the tympanic membrane following the contraction of the stapedius muscle; - a control unit (40) in data communication with the probe (30) and configured to receive data related to the acoustic pressure reflected (35') detected by the microphone unit (35); and - program means (50) connected to said control unit (40) and configured to process the data received from the control unit (40) in such a way as to obtain data indicative of the stapedial reflex and impedance change mapping data corresponding to changes in acoustic pressure reflected (35'). The program means (50) can be connected to display means comprising at least one screen, in such a way as to allow the simultaneous display on a single plane, according to a continuous mode, of data indicative of both the stapedial reflex and the field of dynamic variation of the mapping data generated by the proprietary software of the company manufacturing the cochlear implant or the hearing aid to be adjusted.

Description

Description of the invention patent application with the title: "System for programming cochlear implants and hearing aids based on the detection of the stapedial reflex" on behalf Horentek Sri with headquarters in Santa Croce sull'Arno (PI), Via Provinciale Francesca Sud 141.

DESCRIPTION

Technical field

The present invention refers to the biomedical field, and more precisely refers to a system for detecting the stapedial reflex, in order to aid setting and programming cochlear implants and hearing aids for patients with hearing impairments .

Said system is, in particular, a universal system that, based on the individual needs of a single patient, allows to optimize the operation of cochlear implants and hearing aids of any brand and model.

Description of the state of the art

Human hearing ability is due to sound energy transduction, coming from the external environment, into electric energy, by the cochlea, which provides to send the result of this transduction to the central nervous system in form of nervous impulses. When sound waves penetrate inside the ear, the displacement of liquid contained in the cochlea makes the small ear lashes vibrate, which operate a mechanical transduction of such vibrations into electrical impulses that can be conveyed to the brain via auditory nerve. The ability of perceiving a wide spectrum of sound frequencies is then related to the role of cochlea of distributing the single tones present in the acoustic stimulation into mechanical vibrations of the ear lashes.

Unfortunately, a plurality of causes and pathological conditions may originate hearing loss, partial or total.

In such situations, patients suffering from hearing loss can, in part, or totally, recover a correct perception of sound through the use of hearing recovery devices, such as, for example, cochlear implants and hearing aids.

The cochlear implants, used in case of especially severe hearing loss, such as profound hypoacusis, are surgically implanted in patients, while hearing aids, intended to patients with less severe hearing loss, are devices placed outside the ear and, numerically, involve the largest number of subjects with hearing deficiencies.

Both such devices require to be regularly set and adjusted in order to allow carriers to perceive sounds correctly . Said setting procedures, more properly indicated in technical jargon by the term "fitting", aim to customize the intensity of the stimulations received from the cochlear implants and from the acoustic equipment worn by the patients, to stimulations values as close as possible to comfortable listening values for each patient.

To date there are no universal fitting systems. Every manufacturer of cochlear implants or hearing aids equips these tools with proprietary software through which to make said adjustments.

For this purpose, the hearing aid technician usually obtains, for each patient, a cochlear map, i.e. a personalized electric audiogram based on the minimum audibility threshold (so-called T-Level or Threshold Level) and maximum audibility threshold (so-called C-Level or Comfort Level), obtained, in the case of the cochlear implants, electrode by electrode.

Among those techniques used for generating the aforementioned audiological map, there are subjective mapping techniques and objective mapping techniques.

The subjective mapping techniques are much less precise and anyway possible only in presence of collaborative patients, capable of providing answer to sound stimulations thereto they are subjected during tests. The identification of the subjective minimum audibility threshold (T-Level) is obtained, in the adult, by a voluntary show of hands or thanks to the conditioned response in the case of children, repeating the same strategies used with tonal audiometry.

The maximum audibility threshold (C-Level) is instead identified using loudness scales on which the patient indicates his own sensations of intensity from minimum to discomfort. This type of collaboration is clearly very difficult on paediatric subjects, or even impractical on subjects suffering from serious disabilities, or on deaf subjects for a long time, therefore lacking in auditory memory, which do not allow them to discriminate and recognize exactly the stimulations provided.

The technicians who therefore require the fitting of the various devices much more prefer to resort to objective mapping techniques, especially in the case of the aforementioned subjects.

The objective mapping techniques for obtaining the individual information are essentially based on the determination of evoked stimulations, in particular those of the acoustic nerve, and on the determination of the stapedial reflex.

The evoked potentials of the nerve (ECAP) play, today, the role of the most used method both because they are detectable in more than 80% of patients, and due to an easy to use, considered that the hardware for stimulation and registration are installed into the receiver/stimulator which is managed by a dedicated software. The limits of this measurement are linked to the fact that the objective evocation threshold almost never corresponds to the subjective thresholds, but is situated within the dynamic field with a wide individual variability. The determination of the ECAP then provides only general information, and de facto it always requires to be accompanied by subjective methods of detection.

The determination of the stapedial reflex (ESRT) , instead, although usable in a smaller percentage of patients (about 60%), when it is evocable, provides a very useful, due to a better precision, reference for the maximum audibility threshold and for the map profile.

The term "stapedial reflex" is to be understood as an unconditional physiological response that implies an intervention of the stapedius muscle, i.e. its contraction reacting to intense sound stimulations and therefore potentially "injurious"; consequently, the detection of the stapedial reflex allows to identify the C-Level, i.e. the maximum level of listening comfort, beyond which sound become noise. The maximum audibility threshold identified by the stapedial reflex, electrode by electrode in the case of fitting of cochlear implants, further enables to build a complete map because its profile can be duplicated and used to go back also to the minimum audibility threshold.

However, the skilled person who intends to adapt a cochlear implant or a hearing aid to the specific threshold values of a single patient is today bound to perform a long series of measures (for example, tympanometry, decay test, etc.), economically expensive, by means of oversized and invasive instrumentation, since they are designed to allow the clinical diagnosis of hearing disorders, rather than regulation of cochlear implants and of hearing aids.

As an example, tympanometers are often used, which instruments are typically found in medical offices, designed and structured for diagnostic purposes, that are able to measure changes of acoustic impedance of the middle ear caused by the contraction of the stapedius muscle reacting to strong stimulations.

These instruments do not represent optimal devices for the sole purposes of fitting of the hearing aids or of the cochlear implants since they imply the execution of more complex tests, therefore with longer duration, with evident low tolerability by patients, especially paediatric patients, who do not tolerate very long tests and suffer prominent emotional stresses.

Furthermore, for example again in the case of paediatric patients, the tympanometry probe is typically much great and invasive, as much as the execution mode of the test, that impose the use of pressurized air inside the ear' s cavity, which induce sensation that are inconvenient and often hardly tolerable, which in many cases force to interrupt and repeat the test.

A further drawback to be noted referring to the current practises lies in that such determination of the stapedial reflex are performed in a punctual mode, and not in continuous mode. This results in a low accuracy of the determination and in high measurement times.

Not only, said current practises also require the simultaneous presence of at least two operators, a specialist and a support technician, to ensure synchronism between the stimulation (acoustic or electrical) and the detection of the stapedial reflex.

In some prior art patent documents, attempts to overcome the problems mentioned above are described.

For example, W0200911939 discloses a cochlear implant able to measure, via a probe, the intensity of the stapedial reflex after the generation of a stimulus by the cochlear implant, thereby enabling the patient to autonomously adapt the functioning of his implant to his own listening needs, without the intervention of a specialist technician.

WO2017147221 discloses a further system equipped with a pressure sensor, situated inside the ear, which sensor detects a response of the stapedial reflex so as to adapt the stimulation intensity of the implant to the patient's threshold values.

However, the aforementioned auto-adaptive systems are limited to a reduced number of latest generation cochlear implants and their use is not transferable to other types of cochlear implants, in particular neither to those cochlear implants already implanted whose adaptation in this sense would require further surgery (if technically possible) , nor to the largest class of hearing aids in general .

WO2014/088578 discloses on the contrary a system able to measure the stapedial reflex characterized by the aim of also performing the fitting of a cochlear implant. However, the system is able to interact only with its own cochlear implants and through a rather long and complex procedure that involves the identification of an individual resonance frequency of the patient before being able to proceed to detect the stapedial reflex.

The technical problem of availability of a detection system of the stapedial reflex, that allows in a fast, reliable and above all universal way, the adjustment of both cochlear implants and hearing aids, is therefore still unsolved . Summary of the innovation

It is therefore aim of the present invention to provide a universal system which allows and facilitates the programming of cochlear implants and hearing aids based on the detection of the stapedial reflex, which allows to show in a precise and reliable way the contraction of the stapedial muscle.

According to a main aspect of the present invention, the determination of the patient's electrical dynamic field, or of the acoustic dynamic field, through detection of the stapedial reflex, easily and effectively allows to adjust the cochlear implants and the hearing aids of any brand and model .

It is also aim of the present invention providing a system for programming cochlear implants and hearing aids based on the detection of the stapedial reflex allowing the generation of an audiological map customized for a single patient .

It is yet aim of the present invention providing a system for programming cochlear implants and hearing aids based on the detection of the stapedial reflex which is easy to use.

It is yet aim of the present invention providing a system for programming cochlear implants and hearing aids based on the detection of the stapedial reflex which allows to perform fitting activities in a short time.

It is thereby aim of the present invention providing a system for programming cochlear implants and hearing aids based on the detection of the stapedial reflex which is easily usable on paediatric subjects or on subjects with impairments .

It is further aim of the present invention providing a system for programming cochlear implants and hearing aids which allows to avoid the use of pressurized. It is a further aim of the present invention providing a system for programming cochlear implants and hearing aids based on the detection of the stapedial reflex which is easily adjustable to the ear anatomy of a single patient.

It is another aim of the present invention providing a system for programming cochlear implants and hearing aids based on the detection of the stapedial reflex in real time.

It is yet another aim of the present invention providing a system for programming cochlear implants and hearing aids based on the detection of the stapedial reflex in a continuous mode during time. It is yet another aim of the present invention providing a system for programming cochlear implants and hearing aids based on the detection of the stapedial reflex which allows, by means of display means, to display on the same plane of mapping also compliance changes due to the contraction of the stapedius muscle.

It is a further aim of the present invention providing a system for programming cochlear implants and hearing aids based on the detection of the stapedial reflex which can make use of a plurality of different sources of electrical or acoustic stimulation.

It is a further aim of the present invention providing a system for programming cochlear implants and hearing aids based on the detection of the stapedial reflex which has a reduced overall dimension.

It is yet aim of the present invention providing a system for programming cochlear implants and hearing aids based on the detection of the stapedial reflex which has low price.

It is furthermore aim of the present invention providing a system for programming cochlear implants and hearing aids based on the detection of the stapedial reflex which overcomes the drawbacks of the state of art. These and other aims are achieved by a system for programming cochlear implants and hearing aids based on the detection of the stapedial reflex, comprising:

- a probe, apt to be inserted in the ear of a user, wherein said probe comprises an emitting source configured to emit a probe tone (31') continuous at a predetermined frequency value within the user's ear channel, in such a way as to generate an acoustic pressure on the tympanic membrane, and a microphone unit, apt to detect in a continuous mode the acoustic pressure reflected during time from the tympanic membrane;

- a control unit (40) apt to receive data relating to the acoustic pressure reflected detected by the microphone unit;

program means, connected to the control unit and that can be connected to display means, configured to process the data received from the control unit regarding the values of acoustic pressure reflected and to allow the simultaneous display and in continuous mode, on a plane of said display means, both of the data of stapedial reflex and of the mapping data generated by the proprietary software of the company manufacturing the cochlear implant or the hearing aid to be adjusted. In particular, the display means include at least one screen configured to allow the simultaneous display on a single plane, according to a continuous mode, both of the data indicative of the stapedial reflex and of the field of dynamic variation of the aforementioned mapping data, preferably showed by means of a single video.

For displaying on a single plane it is understood the visualization of the aforementioned data on a single display or simultaneously, on two screens arranged side by side.

Thereby, the present invention allows to obtain an effective and easy to use system to detect in continuous mode the stapedial reflex in a patient, following the acoustic stimulation of the ear, in order to program cochlear implants and hearing aids in general.

Preferably, the probe according to the present invention comprises a source emitting a probe tone (31') in continuous mode at the frequency of 226 Hz. Alternatively, probe tones having frequencies equal to about 678, 800 and 1000 Hz can be used.

Advantageously, the probe is associated with one or more, preferably a plurality, engagement elements apt to adapt to the user's ear channel.

Said elements can be inserted into soft rubber of size suitable with the anatomy of the user' s ear, whose feature is that of guaranteeing the non-dispersion of the sound pressure of probe tone and/or providing mechanical stability to the coupling of the probe to the ear. According to an embodiment of the invention, the probe can be coupled to the ear by means of a connection element, which allows the probe to anchor to user' s the ear in a stable manner.

This allows the instant detection of the stapedius' action, at any moment the stimulation which causes it occurs .

The system allows to perform the measurements both in "ipsi" mode, i.e. inserting the probe in the same ear which bears the cochlear implant, and in "contra" mode, i.e. inserting the probe in the ear opposite to the one which bears the cochlear implant or the hearing aid, preferably in "contra" mode.

Furthermore, contrary to traditional impedance- meters, the system of the present invention does not preferably incorporate any stimulation source, giving the user maximum flexibility. In fact, it may use stimulations of any type, morphology, level or duration, moreover without any constraint with respect to an acquisition window of certain temporal characteristics. The external stimulation source can be a free vocal source, or a speaker connected to the control unit, or other type of source apt to stimulate the user' s inner ear generating relative changes in contraction of the stapedius muscle. Said source of external stimulation may be a vocal source, for example emitted by an expert technical therapist. This is especially suggested if the technician makes advantage of his experience for modulating the intensity and the frequency of the stimulation.

It is also possible to stimulate more electrodes at the same time, i.e. to detect the stapedial reflex obtained following stimulation induced both electrically and acoustically on a plurality of electrodes simultaneously.

The stapedial reflex is usually activated by tonal stimulations at a sound level of about 70-80 dB SPL over the patient's hearing threshold. It appears to be further activated at lower level of about 20 dB by a "Broad Band Noise" type stimulation.

The intensity of the evocable stimulations is comprised within the range between 60-110dB HL, while the stimulation frequency is comprised within the range 125- 6000 Hz, preferably said frequency has the value of 500, 1000, 2000 and 4000 Hz.

Advantageously, the control unit may be configured to select the source type of external stimulation.

This solution allows for example to connect a source of sound emission to the control unit and to set the stimulation parameters by the control unit. Said control unit may also receive a trigger signal referring to the start of the external stimulation, in such a way as to correlate the corresponding changes in the stapedius muscle to type and duration of the external stimulation. Said stimulation source, in one alternative embodiment, in particular, it may also be an electrical stimulation which can be modulated in intensity and frequency generated by a cochlear implant, the cochlear implant being in electrical communication with said control unit, via an its I/O port. The electrical connection of the cochlear implant to the control unit enables, by sending trigger signals and using program means, to synchronize the stimulation moments to the detection of the stapedial reflex operated by the microphone unit.

Advantageously, the control unit may be connected to the program means via a cable connection or via wireless connection .

In the case of a wireless connection, as it is apparent, a simplification of data transmission in terms of ease of use and overall dimensions of the system is obtained .

The present intention further allows, by using program means connected to the control unit, such as for example PC, tablet, smartphone, contrary to the current instrumentation in use, to display on the same plane of the mapping also the stapedial reflex in a continuous registration mode, enabling the technician not to divert the attention from the stimulation activities and to instantly identify the evoked threshold of the stapedial reflex.

In particular, it allows to perform tests by a single technician without requiring the intervention of other professional roles, as it always happens using the other commonly used instruments, thus also resulting in savings in human resources, as well as in greater speed of execution of said fitting.

Furthermore, the probe of the present invention, thanks to its ergonomics, allows to prevent the use of the headband typically used in current diagnostic impedance meters, thus creating maximum comfort for the patient, especially if a paediatric one.

Moreover, for this last category of patients, the fact that the system allows to avoid the use of compressed air for fitting is another relevant advantage.

The system of the present invention further preferably comprises means for visually signalling the seal of the probe with respect to the ear, and thence prevent the execution of measurements useless for the fitting purposes, such as the tympanometry, thus also allowing the creation of instrumentation with lower costs, more convenient than the impedance meters on the market.

According to the advantageous solution of the present invention, the system further comprises one or more calibration units for the microphone unit.

In particular, the calibration units have respective volumes equal to 0.5, 2 and 5 cm³ and are used by the technician to daily verify the correct reading in volume of the microphone unit. Such calibration units are hollow elements inside thereof the probe is inserted through which an emitting signal is sent and the wave of pressure reflected by the microphone unit is registered.

This solution allows for reliable and repeatable measurements over time.

By means of the present invention, therefore, a plurality of benefits is obtained, first correlated to its universality of use enabling the performing of fitting to any brand and model of cochlear implants and hearing aids. Furthermore, the invention advantageously allows to operate reading in continuous mode enabling more fast and reliable identifications, as well as to perform the fitting without the need to bring the ear under pressure (avoid the so- called "in compliance" tests), allowing an adjustment of the hearing devices that is much more appreciated by patients, especially if paediatric. Moreover, the invention allows to achieve advantages related to ergonomics, compactness and practicality of the proposed system, to its accuracy in determining the observation and control parameters, to its cheapness, intended both as a reduction in the number of human resources required to execute the fitting, and as a true cost of the equipment significantly reduced compared to the current instrumentation, as well as to the speed of execution, which, ultimately, allows to increase the number of daily visits that can be performed by the specialist, as well as, finally, to its flexibility of use for programming of any type of acoustic device.

Thanks to the characteristics and advantages above described, the system of the present invention may therefore universally be used for the programming (fitting) of cochlear implants and hearing aids of any brand and model.

According to a particularly advantageous aspect, the system according to the present invention is configured to implement a method for detecting the stapedial reflex in a patient wearing a cochlear implant (60) or a hearing aid, said method comprising the following steps:

a) emission of a probe tone (31') in continuous mode and at a predetermined frequency value, within the patient's middle ear, so that said probe tone (31') generates an acoustic pressure reflected (35') from the tympanic membrane following the contraction of the stapedius muscle of the ear (20) of the patient;

b) detection and acquisition, in continuous mode, of first data relating to said acoustic pressure reflected (35') generated by said probe tone (31');

c) determination of a reference status corresponding to said acoustic pressure reflected (35') generated by said probe tone ( 31 ' ) ;

d) production of an external stimulation of the cochlear implant or of the hearing aid of the patient;

e) detection and acquisition, in continuous mode, of secondi data relating to said acoustic pressure reflected (35') from the tympanic membrane;

f) processing of said second data in such a way as to obtain data indicative of the stapedial reflex and data related to the changes in impedance corresponding to changes in acoustic pressure reflected (35'); and

g) simultaneous display, on a single plane, according to a continuous mode, both of said data indicative of the stapedial reflex and of the field of dynamic variation of mapping data generated by the proprietary software of the company manufacturing the cochlear implant or the hearing aid worn by the patient, to be adjusted. In particular, the system according to the present invention is configured to implement a method for programming cochlear implants and hearing aids based on the detection of the stapedial reflex. Such method, according to an embodiment, comprises the following steps of:

- introduction of a probe inside the cavity of an ear of a subject wearing cochlear implant or hearing aid, said probe comprising:

• an emitting source configured to emit a continuous probe tone at a predetermined frequency value within the user' s middle ear, so as to generate a determined acoustic pressure reflected from the tympanic membrane following the contraction of the ear's stapedius muscle;

• a microphone unit apt to detect in a continuous mode the acoustic pressure reflected during time from the tympanic membrane following the contraction of the stapedius muscle;

- acquisition of data relating to the acoustic pressure reflected detected by the microphone unit by means of a control unit; - processing data received relating to the values of acoustic pressure reflected by means of a program for processor;

- displaying, in continuous mode and on a single screen, the field of dynamic variation of impedance corresponding to changes in reflected pressure of the probe tone correlated to the contraction of said stapedius muscle and of mapping data generated by the proprietary software of the company manufacturing the cochlear implant or the hearing aid to be adjusted.

Brief description of the drawings

Further characteristics and/or advantages of the present invention will be more apparent by the following description of an its embodiment, made as a non-limiting example, referring to the attached drawings wherein:

- Figure 1 schematically shows an example of system for detecting the stapedial reflex according to the present invention;

- Figure 2 shows an exemplary flow chart of the program means, according to the present invention, for a calibration operation of the system;

Figure 3 shows an exemplary flow chart for the steps of programming cochlear implants and hearing aids by means of the system according to the present invention .

Description of several preferred embodiments

Referring to Figure 1, a possible embodiment is showed for a system for programming cochlear implants and hearing aids based on the detection of the stapedial reflex. In particular, the user, that wears a cochlear implant 60, is frontally stimulated by an external stimulation source 10, for example an audio speaker. In particular, the external stimulation source 10 may be a headset that can be worn by the user by which an audio signal with frequency, amplitude, waveform and emission time precisely defined is emitted. Alternatively, the external stimulation may be a vocal stimulation emitted in open field by a specialist, i.e. the external stimulation source 10 is a vocal type.

The system comprises a probe 30, apt to be inserted in the ear 20 of a user. The probe 30 comprises an emitting source 31, which is configured to emit a continuous probe tone 31' at a predetermined frequency value within the user's ear channel, so as to generate a determined acoustic pressure reflected 35' of the tympanic membrane 20. The frequency of the signal probe is preferably a frequency equal to 226 Hz. Alternatively, it may also be a signal at frequency equal to 678, 800, 1000 Hz. The probe 30 further comprises at least one microphone unit 35, which is able to detect very small changes in acoustic pressure reflected 35' from the tympanic membrane following the stimulation dosing by both the external stimulation source 10 and the probe tone 31' .

For example, the microphone unit contained within the probe 30 is able to detect muscle contractions, corresponding to volumetric contractions of the external ear channel, with a resolution greater than 0.0025 cc, preferably in the order of about 0.0010 cc.

The chance for the microphone unit to detect muscle contractions with a resolution equal to about 0.0010 cc makes the system preferably operate with a probe tone having frequency equal to 226 Hz.

Therefore, preferably the system functions with a probe tone 31' that emits a signal with frequency equal to 226 Hz and a microphone unit 35 having a resolution of about 0.0010 cc .

The system further comprises a control unit 40, in communication with the probe 30. The control unit 40 is apt to receive data relating to changes in pressure reflected 35' detected by the microphone unit 35. The control unit 40 may also advantageously be in communication with the external stimulation source 10 in order to manage the stimulation generation modes. Program means 50, connected to the control unit 40, are configured to process data received from the microphone unit 35, and relating to values of acoustic pressure reflected 35' and to provide indications on the dynamic field of changes in impedance corresponding to the changes of the probe tone 31' reflected correlated to the contraction of the stapedius muscle.

For example, the therapist would display on an elaborator, or on a tablet or on a smartphone, the levels of minimum and maximum threshold of acoustic stimulations that can be sensed by the user by consequently setting the comfort threshold.

On a practical level, in case of setting cochlear implants, said determination is performed for each cochlear implant's channel and for each frequency.

In such a way, the therapist is able to program both cochlear implants and hearing aids on said maximum threshold values and, based on the knowledge of said maximum threshold values, to obtain the corresponding minimum threshold values.

As anticipated, the system according to the present invention is configured to implement a method for detecting the stapedial reflex in a patient wearing a cochlear implant

(60) or a hearing aid. Such method substantially comprises the following steps :

a) emission of a probe tone (31') in continuous mode and at a predetermined frequency value, within the patient's middle ear, so that said probe tone (31') generates an acoustic pressure reflected (35') from the tympanic membrane following the contraction of the stapedius muscle of the ear (20) of the patient; b) detection and acquisition, in continuous mode, of first data relating to said acoustic pressure reflected (35') generated by said probe tone (31'); c) determination of a reference status corresponding to said acoustic pressure reflected (35') generated by said probe tone (31');

d) production of an external stimulation of the cochlear implant of the patient;

e) detection and acquisition, in continuous mode, of second data relating to said acoustic pressure reflected (35' ) from the tympanic membrane; f) processing of said second data in such a way as to obtain data indicative of the stapedial reflex and impedance change mapping data corresponding to changes in acoustic pressure reflected (35'); and g) simultaneous display, in continuous mode and on a single screen, both of said data indicative of the stapedial reflex and of the mapping data generated by the proprietary software of the company manufacturing the cochlear implant or the hearing aid to be adjusted.

Referring to Figure 2, an exemplary flow chart for a calibration operation of the system is showed in detail.

Prior to starting the stimulation procedure of the stapedial reflex, a preliminary test 201 apt to verify if the trace of acquisition of the microphone unit 35 is stably on the threshold value zero is planned. It is therefore provided the starting of the test 202 with placement of the probe 30 within the ear channel in absence of external stimulation 203. In the case of a pressure value reflected 35' detected by the microphone unit 35 equal to zero for a predetermined time, i.e. for a time longer than 10 seconds 204, then the test can be considered completed 205, and it is therefore possible to provide indications to the user on the correct behaviour to be taken during the test. In the case of the pressure value reflected 35' detected by the microphone unit 35 not being equal to about zero, thence the probe 30 is repositioned and the test is repeated again.

Referring to Figure 3, it is showed in detail an exemplary flow chart for the steps of the method for programming cochlear implants and hearing aids. In particular, a step 303 of introduction of the probe 30 inside the cavity of the user' s ear and measurement of the stapedial reflex by sending a probe tone 31' is provided. The signal sent by the probe 10 generates a stimulation on the membrane corresponding to a pressure on the wall. The zero of the system is generated on such pressure value reflected. It is further provided a step of choosing the stimulation type 302. The therapist is requested to choose between the generation of an electrical stimulation through the cochlear implant's channels 303' or an acoustic stimulation 303. In both cases, the therapist is requested to choose the stimulation parameters in terms of frequency, intensity and duration of the stimulation, so as to obtain the range of audibility for each electrode of the cochlear implant .

In the case of reflex value detected outside a predetermined critical band, a filter is then applied to a signal, or the choice of the stimulation parameters 304 is repeated .

In the case of reflex value detected outside a predetermined critical band, the audibility range which defines the comfort level (MCL) results to be obtained and consequently the setting data for each patient is saved.

It is to be understood that others, using the prior art, will be able to modify and/or adapt through various applications the specific embodiments of the present invention above described, using the same innovative concept .

The means and materials to carry out the various functions described may be of various kinds without leaving the scope of protection of the present invention.

It is understood that expressions or terminology are used as purely descriptive and as a non-limiting example.

Claims

1. Universal system (100) for detecting the stapedial reflex in a patient wearing a cochlear implant (60) or a hearing aid at an ear, when the patient undergoes an external stimulation of the cochlear implant (60) or of the hearing aid, comprising:

- a probe (30) apt to be inserted in the ear (20) of the patient, said probe (30) comprising:

• an emitting source (31) configured to emit a probe tone (31') in continuous mode, at a predetermined frequency value, within the patient's middle ear, so that said probe tone (31') generates an acoustic pressure reflected (35') from the tympanic membrane following the contraction of the stapedius muscle of the ear (20); and

• at least one microphone unit (35) apt to detect, in continuous mode, said acoustic pressure reflected (35') from the tympanic membrane;

- a control unit (40) in data communication with said probe (30), said control unit (40) being configured to receive data relating to said acoustic pressure reflected (35') detected by said microphone unit (35) ;

- program means (50), connected to said control unit (40), said program means (50) being configured to process said data received from said control unit

(40) in such a way as to obtain data indicative of the stapedial reflex and impedance change mapping data corresponding to changes in acoustic pressure reflected (35' ) , wherein said program means (50) is apt to be connected to display means comprising at least one screen, in such a way as to allow the simultaneous display on a single plane, according to a continuous mode, of both of said data indicative of the stapedial reflex and of the field of dynamic variation of mapping data generated by the proprietary software of the company manufacturing the cochlear implant (60) or the hearing aid worn by the patient .

2. System (100) according to claim 1, wherein said probe tone (31') has a frequency comprised between about 200 Hz and about 1.000 Hz.

3. System (100) according to claim 1 or 2, wherein said probe tone (31') has a frequency equal to about 226 Hz, 678

Hz, 800 Hz or 1.000 Hz, more preferably equal to about 226 Hz .

4. System (100) according to any of the preceding claims, wherein said probe (30) is associated with one or more engagement elements, configured to adapt to the patient's ear channel.

5. System (100) according to the preceding claim, wherein said engagement elements are configured to avoid the dispersion of the sound pressure of said probe tone (31') and/or to provide mechanical stability to the coupling between said probe (30) and the ear, said engagement elements comprising for example soft rubber inserts.

6. System (100) according to any of the preceding claims, wherein said microphone unit (35) is configured to detect contractions of the stapedius muscle with a resolution greater than about 0.0025 cc, preferably in the order of about 0.0010 cc.

7. System (100) according to any of the preceding claims, comprising one or more external stimulation sources (10) of the patient configured to emit an acoustic signal or an electrical signal having predetermined frequency, amplitude, waveform and emission time.

8. System (100) according to the preceding claim, wherein said control unit (40) is connected to said one or more external stimulation sources (10) and is configured to determine the activation thereof in a selective manner and to set the respective stimulation parameters.

9. System (100) according to claim 7 or 8, wherein said one or more external stimulation sources (10) comprise a source of acoustic stimulation, comprising an audio speaker or a headset that can be worn by the patient.

10. System (100) according to any of claims from 7 to 9, wherein said one or more external stimulation sources (10) comprise a cochlear implant (60) worn by the patient and apt to realize an electrical stimulation, said cochlear implant being connected to said control unit (40) .

11. System (100) according to any of claims from 7 to 10, wherein said one or more external stimulation sources are applied to the patient's ear wherein the cochlear implant (60) is installed or to the patient's ear wherein the cochlear implant (60) is not installed.

12. System (100) according to any of the preceding claims, wherein said control unit (40) is configured to receive a trigger signal at the starting of the patient's external stimulation, in such a way as to associate said data related to the acoustic pressure reflected (35') to the specific type and duration of external stimulation.

13. System (100) according to any of the preceding claims, wherein said program means (50) are connected to said control unit (40) in a wireless mode.

14. System (100) according to any of the preceding claims, wherein said program means (50) comprise a PC, a tablet or a smartphone . 15. System (100) according to any of the preceding claims, comprising said display means, which display means includes at least one screen configured to allow the simultaneous display on a single plane, according to a continuous mode, both of said data indicative of the stapedial reflex and of the field of dynamic variation of said mapping data.

16. System (100) according to any of the preceding claims, comprising means for visually signalling the seal of said probe (30) with respect to the ear.

17. System (100) according to any of the preceding claims, comprising one or more calibration units of said microphone unit (35), which preferably have respective volumes equal to about 0.5 cm³, 2 cm³ and 5 cm³.

18. Method for detecting the stapedial reflex in a patient wearing a cochlear implant (60) or a hearing aid at an ear, which can be implemented by means of a system (100) according to any of the preceding claims, said method comprising the following steps: a) emission of a probe tone (31') in continuous mode and at a predetermined frequency value, within the patient's middle ear, so that said probe tone (31') generates an acoustic pressure reflected (35') from the tympanic membrane following the contraction of the stapedius muscle of the patient's ear (20); b) detection and acquisition, in continuous mode, of first data relating to said acoustic pressure reflected (35') generated by said probe tone (31'); c) determination of a reference status corresponding to said acoustic pressure reflected (35') generated by said probe tone (31'); d) production of an external stimulation of the cochlear implant or of the hearing aid of the patient ; e) detection and acquisition, in continuous mode, of second data relating to said acoustic pressure reflected (35' ) from the tympanic membrane; f) processing of said second data in such a way as to obtain data indicative of the stapedial reflex; g) simultaneous displaying, on a single plane, according to a continuous mode, both of said data indicative of the stapedial reflex and of the field of dynamic variation of mapping data generated by the proprietary software of the company manufacturing the cochlear implant or the hearing aid worn by the patient. 19. Method according to the preceding claim, comprising a step of choosing the type of external stimulation among one of the following types: electrical stimulation (303') through cochlear implant's channels or acoustic stimulation (303) . 20. Method according to claim 18 or 19, comprising a step of setting at least one of the following parameters (304) of external stimulation: frequency, intensity and duration of the stimulation.

21. Method according to any of claims from 18 to 20, comprising a preliminary test step (201) to verify that the data relating to said acoustic pressure reflected (35') are stably on a threshold value equal to zero, before said step a) .

22. Method according to the preceding claim, comprising a further test step (202), subsequent to the preliminary test step (201) and preceding to the step a), wherein, in absence of external stimulation (203) and in continuous mode, said data relating to said acoustic pressure reflected (35') are detected; if said acoustic pressure reflected (35') is equal to zero for a predetermined time, preferably for a time longer than 10 seconds (204), said further test step (202) is considered completed (205) and indications are given on the correct behaviour that the patient must take during the detection of the stapedial reflex; if the acoustic pressure reflected (35') is greater than zero, said further test step (202) is repeated again.

23. Method according to any of claims from 18 to 22, wherein said step a) comprises a step (303) of introduction of a probe (30) inside the cavity of the patient's ear (20), wherein said probe (30) is configured to emit said probe tone ( 31 ' ) .

24. Method according to any of claims from 18 to 23, wherein if said external stimulation signal has a value comprised in a predetermined critical band, a filter is applied to said external stimulation signal or parameters (304) of external stimulation, such as frequency, intensity and duration of the stimulation, are varied and said external stimulation is repeated.

25. Method according to any of claims from 18 to 24, which does not provide any step of introduction of compressed air into the patient's ear.