Patent Application
20230001206
The present application claims priority to EP Patent Application No. EP21183758, filed Jul. 5, 2021, the contents of which are hereby incorporated by reference in their entirety.
Hearing prosthesis systems may use electrical stimulation of the cochlea via the electrode array only or, for patients with residual hearing, the system in addition may apply acoustic stimulation (such bimodal stimulation systems are known as EAS-systems). Hearing prosthesis systems have to be adapted to the individual patient by fitting sessions, wherein fitting parameters, such as electrical stimulation or acoustic stimulation threshold levels, acoustic amplification gains for EAS-patients, etc., are determined and set. Since the condition of the patient's hearing and electrode conditions may vary over time, regular assessment of the performance of the hearing prosthesis system by monitoring the operating parameters is desirable. In particular, shifts of the steady state parameters should be determined and the normal viability thereof should be tracked.
Assessment of the system performance may include objective measurements, such as measurement of electrocochleography (ECochG) thresholds, neural response imaging (NRI) thresholds and cortical responses, via the electrode array, wherein the measured electrical signals are transmitted via back-telemetry to the external processing unit. Such measurements involve electrical stimulation via the electrode array and/or acoustic stimulation (in case of EAS systems). Such hearing stimulation often involves an audible or at least noticeable percept that is not consistent with normal stimulation pattern and therefore is considered unnatural by user. As a consequence, such system performance measurements typically are conducted only at visits of the patient to the hearing care professional (HCP), which may be infrequent and/or irregular.
WO 2020/044307 A1 relates to a hearing prosthesis system wherein stimulation for objective measurements of system performance is applied during times when a state of sleep of the patient has been determined, so as to avoid that the patient is disturbed by the hearing stimulation required for the objective measurements.
US 2017/0304632 A1 relates to a cochlear implant system wherein automated ECochG testing outside of a clinical setting is performed using the normal sounds that a patient hears in the course of the daily life. To this end, ambient sound signals received by the cochlear implant system during normal operation are analyzed to identify portions of sound signals that are suitable for performing an ECochG measurement using the implanted electrode array. The ECochG measurements are used for assessing the patient's residual hearing, so as to initiate corrective actions if a change of the residual hearing is detected.
Hereinafter, examples of the invention will be illustrated by reference to the attached drawings, wherein:
Described herein is a hearing prosthesis system comprising an implantable electrode array, a cochlear implant coupled to the electrode array, and a processing unit communicatively coupled to the cochlear implant.
In some embodiments, a hearing prosthesis system is provided which allows for relatively regular monitoring of the system performance in a patient-friendly manner.
The embodiments described herein may utilize a user interaction audio signal which is indicative of an interaction of the patient with the hearing prosthesis system as a test audio signal for applying perceivable hearing stimulation to the patient according to the user interaction signal and to detect, via the electrode array, a neural response of the patient to such hearing stimulation. Thereby objective system performance measurements can be conducted in an unobtrusive manner on a relatively frequent basis during normal use, in particular outside a clinical setting, of the hearing prosthesis system.
In some implementations, the user interaction audio signal is a feedback message signal indicative of a user interaction on a user interface of the hearing prosthesis system or a status message signal indicative of a change in a condition of the hearing prosthesis system. For example, the feedback message signal may be indicative of a user action resulting in a hearing program change, a volume increase, a volume reduction or locking or unlocking of the implant. For example, the status message signal may be indicative of a wireless connection or disconnection of the external processing unit with external device, or it may be indicative of a low battery status.
In some implementations, the user interaction audio signal is selected such that is perceivable by the patient as a standard sound associated with the respective feedback message or a status message.
In some implementations, the feedback message signal is in response to a user action on an operator control. For example, the operator control may be a mechanical element disposed on an external housing including the processing unit; for example, the operator control may be a button or a key to be pressed. According to another example, the operator control may be provided on a remote control device communicatively coupled with the processing unit; for example, the operator control may be implemented as a touch screen of the remote control device. According to still another example, the feedback message signal may be in response to a user action on an operator control of an accessory device communicatively coupled to the processing unit; for example, the accessory device may be smartphone and the user action may be locking or unlocking of a touchscreen of the smartphone.
In some implementations, the processing unit is configured to apply the perceivable hearing stimulation corresponding to the user interaction audio signal at a level within the comfort range.
In some implementations, the user interaction audio signal includes sinusoidal tones and/or frequency sweeps.
In some implementations, the recording of the neural response to the user interaction audio signal includes neural response imaging (NRI) threshold measurements, electrocochleography (ECochG) threshold measurements, cortical response measurements and/or electrode impedance measurements.
In some implementations, the processing unit is configured to apply said perceivable hearing stimulation to the patient according to the user interaction audio signal as electrical stimulation via the electrode array. For example, the processing unit may be configured to select only some of the electrodes of the electrode array which are found to characterize the fitting curves and to use only the selected electrodes for the electrical stimulation according to the user interaction audio signal.
In some implementations, the hearing prosthesis system is an EAS system including an electroacoustic output transducer, wherein the processing unit is configured to apply said perceivable hearing stimulation to the patient according to the user interaction audio signal as acoustic stimulation via the electroacoustic output transducer. Fore example, the recording of the neural response to the user interaction audio signal may include measurement of ECochG signals.
In some implementations, the processing unit is configured to automatically adjust fitting parameters of the hearing prosthesis system according to the recorded neural response. For example, the processing unit may be configured to automatically adjust stimulation threshold levels of the hearing prosthesis system according to the recorded neural response, and wherein the user interaction audio signal may result in hearing stimulation suitable for determining the respective threshold from the recorded neural response; for example, the recording of the neural response to the user interaction audio signal may include cortical response measurements for adjustment of electrical stimulation thresholds.
In some implementations, the processing unit is configured to store data corresponding to neural responses recorded over a time period for later use in manual adjustment of fitting parameters.
In some implementations, the processing unit is integrated an external unit. For example, the external unit may be configured to be worn at the patient's head; for example, the external unit is a BTE unit or a headpiece.
In some implementations, the cochlear implant and the processing unit are coupled via an inductive transcutaneous link, wherein the neural response to the user interaction audio signal is supplied to the processing unit by back telemetry via the inductive transcutaneous link.
The processing unit 108 is configured to direct the cochlear implant 102 to apply stimulation to the cochlea 200 via the electrodes 106 of the electrode array 104 and to direct the electroacoustic output transducer 110 to apply acoustic stimulation to the patient so as to stimulate the residual hearing of the patient. To this end, the processing unit 108 generates corresponding electrical stimulation signals which are supplied to the cochlear implant 102 and acoustic stimulation signals which are supplied to the electroacoustic output transducer 110. The processing unit 108 may generate such stimulation signals based on audio input signals received from the microphone 114 or an audio input 118 which may be, for example, a communication interface to an accessory device, such as a smartphone or an audio streaming device, so as to stimulate, in a normal operation mode, the hearing of the patient according to the input audio signals to make the input audio signals perceivable by the patient.
Further, the processing unit 108 may generate electrical and/or acoustic stimulation signals in response to a user interaction with the user interface 112, so as to provide a feedback message, such as a characteristic tone, to the patient, and/or the processing unit 108 may generate the stimulation signals according to a status change of the system, such as a wireless connection or disconnection of the processing unit with an external device, such as a smartphone, or to indicate a low battery status. To this end, the processing unit 108 may be coupled to respective sensors 120 which sense certain system conditions such as battery status.
Electrical stimulation via the electrodes 106 and/or acoustic stimulation or via the output transducer 110 results in a neural response of the patient to such hearing stimulation, which neural response can be detected via the electrode 106 of the electrode array, with the detected neural response signals being supplied via the cochlea implant 102 to the processing unit 108 for analysis of neural response signals.
As already mentioned above, the processing unit 108 may generate a user interaction audio signal which is indicative of an interaction of the patient with the hearing prosthesis system 100, and apply perceivable hearing stimulation to the patient according to the user interaction audio signal. The user interaction audio signal, for example, may be a feedback message signal indicative of a user action, in particular an action by the patient, on the user interface 112 or a status message signal indicative of a change in a condition of the hearing prosthesis system, such as sensed by the sensors 120.
The processing unit 108 further may record, via the electrode array 104 and the cochlear implant 102, the neural response to such hearing stimulation according to such user interaction audio signal, thereby utilizing the user interaction audio signal as a test audio signal. In this way hearing prosthesis performance can be monitored by performing relatively frequently active objective neural response measurements in a relatively unobtrusive way, i.e. without disturbing the patient by perception of unexpected or unusual hearing sensations, so that implant health and operation parameter fitting can be monitored during normal use of the hearing prosthesis by the patient. In particular, the test audio signals thereby can be designed in a manner that the patient experiences the expected perception of user interface feedback and/or status information. In other words, the patient perceives usually expected standard sounds/signals only. In particular, any signal tone may consist of suitable measurement stimuli for purposes such as fitting of the electrical and/or acoustical path. In other words, a user interaction with the hearing prosthesis actually triggers an active measurement with a stimulus at a level to be clearly perceivable, while the patient actually does not recognize that a neural response measurement presently takes place.
The perceivable hearing stimulation corresponding to the user interaction audio signal may be applied at a level within the comfort range of the patient.
In some examples, the user interaction audio signals may include sinusoidal tones and/or frequency sweeps.
In some implementations, known previously used measurement signals may be modified so as to be clearly audible to the patient and create a pleasant perception which is similar or equal to a standard sound perception typical for user interaction with the hearing prosthesis system. Further, known previously used common user interaction audio signals, such as user interface feedback sounds, may be modified so as to be suitable for performing neural response measurements, while still being perceivable as a standard sound. Generally, also new stimuli may be designed, as long as the patient feels to perceive some kind of standard user interaction sound, while the patient should not have the feeling of a measurement being performed.
Examples of interactions of the patient with the hearing prosthesis system are schematically shown in
According to another example, the interaction of the patient with the user interface 112 may be the locking or unlocking of a screen of a smartphone communicatively coupled, for example, via a Bluetooth connection, to the processing unit. In this case, the processing unit 108 may perform, for example, an electrode impedance measurement when such unlocking or locking of the smartphone screen happens, which will cause a noticeable short sound which equals or is similar to a sound typically used for indicating screen locking/unlocking. The processing unit 108 then may verify that the resulting impedance measurements are within the expected range or, alternatively or in addition, it may store the measurement values in the memory 116 for long-term trend analysis.
In some implementations, the feedback message signal may be in response to a user interaction on an operator control, which, for example, may be a mechanical element disposed on an external housing including the processing unit 108; in particular, the operator control may be a button or a key to be pressed. In another example, the operator control may be provided on a remote control device communicatively coupled with the processing unit 108; for example, the operator control in this case may be implemented as a touchscreen of the remote control device. In some implementations, the feedback message signal may be in response to a user action on an operator control of an accessory device coupled to the processing unit 108; in particular, the accessory device may be a smartphone and the user action may be locking or unlocking of a touchscreen of the smartphone, as already mentioned above.
The recording of the neural response to the user interaction audio signal may include NRI threshold measurements, ECochG threshold measurement, cortical response measurements and/or electrode impedance measurements.
For applying electrical stimulation according to the user interaction audio signal the processing unit 108 may select some of the electrodes 106 of the electrode array 104, namely those electrodes which are found to characterize the fitting curves of the hearing prosthesis system. Accordingly, it is sufficient to use only these selected electrodes for the electrical stimulation according to the user interaction audio signal, i.e., for the neural response measurements; there is no need to use all electrodes.
In case that the hearing prosthesis system provides also for acoustic stimulation, measurement of ECochG signals is particularly useful.
For example, an acoustic sound could be presented via the output transducer 110 at different frequencies and the resulting ECochG signals may be measured via the electrodes 106. With the measured values the acoustic threshold could be estimated and compared to the present setting, and subsequently could be adjusted automatically if required.
Electrical stimulation via the electrodes 106 may be used for evoking and measure cortical potentials. Such cortical potential measurements can be used for validating the electrical threshold levels and to automatically adjust the levels if required, as described, for example, in U.S. patent application 62/926,351, which application is incorporated herein by reference in its entirety.
In general, the recorded neural responses may be used by the processing unit 108 to automatically adjust all kinds of fitting parameters, not only threshold levels.
Alternatively or in addition, the processing unit 108 may store data corresponding to the neural responses recorded over a time period in the memory 116 for later use in manual adjustment of fitting parameters, for example, by a hearing care professional.
An example of a practical implementation of the system illustrated in
The neural response signals detected by the electrodes 106 may be supplied to the sound processor 202 by back-telemetry via the inductive transcutaneous link 210.
| Number | Date | Country | Kind |
|---|---|---|---|
| EP21183758 | Jul 2021 | EP | regional |
