Assessment of Novel Sound Changing Principles in Hearing Instruments to Determine Their Application - Sonova2018_31

Study Overview
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Brief Summary
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A methodical evaluation of sound changing principles in CE-labelled Sonova brand hearing instruments (e.g. Phonak hearing instruments) is intended to be conducted on hearing impaired participants. These sound changing principles are enabled by respective hearing instrument technologies and hearing instrument algorithms. The aim of the study is to investigate and asses strength and weaknesses of these sound changing principles in terms of hearing performance to determine their application in hearing instruments (Phase of development). Objective laboratory measurements will be carried out. This will be a controlled, single blinded and randomised active comparator clinical evaluation which will be conducted mono centric at Sonova AG Headquarter based in Stäfa

Official Title
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Assessment of Novel Sound Changing Principles in Hearing Instruments to Determine Their Application

Conditions
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Hearing Loss

Intervention / Treatment
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* Device: Bolero B90-SP


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Adult hearing impaired persons (minimum age: 18 years) with or without experience with hearing aids Sensorineural hearing loss (N4-N6 according to ISO 60118-15) Good written and spoken (Swiss) German language skills Healthy outer ear Informed Consent as documented by signature Symmetric hearing loss below 1000 Hz Exclusion Criteria: Contraindications to the MD in this study, e.g. known hypersensitivity or allergy to the investigational product Limited mobility and not in the position to attend weekly appointments on study site Inability to produce a reliable hearing test result Known psychological problems Central hearing disorders

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 99 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Interventional Model Description: Crossover Assignment Each participant will be treated with each test condition in a randomized order.
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Hearing Aid with beam form principle_A<br>Device: Hearing Aid beam former principle_A (simulation of real ear condition). Each participant will be fitted with the 3 different beam former (directionality change) principles on the same hearing aid, saved to 3 manual programs. Beam former principle is a sound processing algorithm to focus to a target source in a noisy situation to improve the speech intelligibility and comfort. The experimental conditions vary in their parametrization to result in different degrees of beam forming and good speech quality. | Device: Bolero B90-SP<br>* Behind the ear Hearing device fitted with an individual ear mold to compensate a Hearing loss<br>|
| Experimental: Hearing Aid with beam form principle_B<br>Device: Hearing Aid beam former principle_B. Each participant will be fitted with the 3 different beam former (directionality change) principles on the same hearing aid, saved to 3 manual programs. Beam former principle is a sound processing algorithm to focus to a target source in a noisy situation to improve the speech intelligibility and comfort. The experimental conditions vary in their parametrization to result in different degrees of beam forming and good speech quality. | Device: Bolero B90-SP<br>* Behind the ear Hearing device fitted with an individual ear mold to compensate a Hearing loss<br>|
| Experimental: Hearing Aid with beam form principle_C<br>Device: Hearing Aid beam former principle_C. Each participant will be fitted with the 3 different beam former (directionality change) principles on the same hearing aid, saved to 3 manual programs. Beam former principle is a sound processing algorithm to focus to a target source in a noisy situation to improve the speech intelligibility and comfort. The experimental conditions vary in their parametrization to result in different degrees of beam forming and good speech quality. | Device: Bolero B90-SP<br>* Behind the ear Hearing device fitted with an individual ear mold to compensate a Hearing loss<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Individual binaural Hearing abilities | Primary Outcome measurement is to measure the speech understanding in noise [SNR in dB] for the beam former principles A, B and C | 2 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Speechunderstanding for different beam form principles | Secondary Outcome measurement is to measure individual binaural Hearing abilities with psycho acoustical test principles (Binaural inter aural Level difference [SNR in dB] and Binaural Masking Level Difference [SNR in dB] and speech test [Oldenburger Satztest in noise [SNR in dB]. Thereby, the correlation between psycho acoustical test results and speech test results will be analyzed. | 2 weeks |