Study of SelfFit Mobile Medical App for Hearing Loss Diagnostics and Hearing Device Fitting / Fine Tuning

Study Overview
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Brief Summary
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The purpose of this clinical study is to validate the comparability of prescription formula fitting of hearing aids based on full diagnostic audiometry and SelfFit interactive fitting of hearing aids based on hearing loss screening (mild to moderate hearing losses) using in-situ audiometry, provided and executed through the mobile medical app.

Detailed Description
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The technology utilized within the mobile medical App is partially described in the US patent application US2011/0002490A1. The app is to be used in combination with a hearing aid to deliver the output and targets accurate individual acoustical amplification for effective compensation of a users hearing loss. The electronic circuitry incorporating the digital signal processing algorithms - dynamic range compression, noise reduction - is providing the acoustical amplification according to parameters (acoustical gain, compression ratio, time constants) calculated through the App on base of in-situ hearing loss diagnostics (pure tone audiometry, loudness scaling). Within the study, amplification parameters will be transmitted to the prototyped device through a prototyped audio streaming box. Individual audiogram represents hearing thresholds (softest audible sounds) at different frequencies. At least two test frequencies are used involving one in the lower region of device's bandwidth (such as 750 Hz) and one in the higher region of the device's bandwidth (such as 2 kHz). Hearing thresholds are assessed by presenting pure tones of different known levels (SPL) to the user and the thresholds for each of the test frequencies are determined according to the user response to a verbally formulated question (how many tones did you hear?) and multiple choice answer buttons (0, 1, or 2). Second hearing loss characteristic obtained by the app. is the personal loudness scaling. By presenting a band-limited noise stimuli and collecting the user response about perceived loudness level Medical Mobile App calculates dynamic range of users hearing at given frequency. The calculation of optimal amplification parameters is performed by App using a proprietary fitting formula derived from scientific data. Final adjustment of amplification parameters called fine tuning is performed while presenting the user with realistic acoustical environment during operation of the hearing device. Fine tuning relates to slight changes of the parameters initially obtained by the fitting formula. The acoustical signals are presented using audio streaming through the hearing aid. In particular the presented signals include speech in quiet and speech in background noise. Presented speech signal is composed from two or more sources that are processed with different signal processing parameters. During the presentation of the speech signal App presents the speech source visually as two or more speakers. The user is asked to provide his listening preference by choosing the preferred speaker. The signal processing parameters relating to the preferred sound are used for final adjustment of hearing device.

Official Title
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Study of SelfFit App for Hearing Loss Diagnostics Based on Threshold Measurements Through In-situ Audiometry and Adjustment of Hearing Device Amplification Parameters in Agreement With Prescriptive Formulas as NAL-NL1,DSL-i/o

Conditions
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Mild to Moderate Sensorineural Hearing Loss

Intervention / Treatment
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* Device: SelfFit adjusted hearing device


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Hearing loss at the better ear between 35dB and 50dB (PTA1/2/4) Active lifestyle No language problems No medical contra-indications Age: between 18 and 75 years About 50% experienced users and 50% new users Willing to participate in the trial with one three hour visit to the AMC. Exclusion Criteria: Conductive hearing loss in the middle ear Severe hearing loss

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: SelfFit adjusted hearing device<br>Hearing impaired people with mild to moderate sensorineural hearing loss (PTA124<50 dB) in the test ear compare the performance of their hearing aids adjusted through SelfFit mobile medical App (I-Pad) with the performance of their hearing aids adjusted through conventional audiogram-based fitting. | Device: SelfFit adjusted hearing device<br>* Comparison of threshold measurements through in-situ audiometry with full diagnostic audiometry; Comparison of First-Fit based on SelfFit-formula with conventional fitting formula NAL-NL1 (IG-measurements; Speech intelligibility with First fit of SelfFit; Speech intelligibility with Final fit of SelfFit; Comparison of fine tuning through SelfFit (Final fit) with First fit; Comparison of Final fit with Traditional fit (conventional fitted hearing aid of the test person)<br>* Other names: home-fitting tool for hearing devices;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Hearing threshold | Applicability of in-situ audiometry: Comparison of pure tone audiometry outcomes: conventional full diagnositic and SelfFit in-situ audiometry | June - July 2013 (up to 2 months) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Speech intelligibility - First Fit | Quality of First-Fit: Comparison speech audiometry with CVC words @ 55/65/75 db SPL in conventionally adjusted hearing aid and SelfFit adjusted hearing aid | June - July 2013 (up to 2 months) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Audiology, hearing loss, hearing healthcare, mobile app, hearing aid fitting, audiometry, audiogram