Assessment of Novel Measurement and Fitting Methods to Determine Their Reliability, Validity and Application - Sonova2018_34

Study Overview
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Brief Summary
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A methodical evaluation of novel measurement and fitting methods for individualizing CE-labelled Sonova brand hearing instruments (e.g. Phonak hearing instruments) is intended to be conducted on hearing impaired participants. The aim of the study is to investigate and asses strength and weaknesses of these novel measurement and fitting methods in terms of optimizing hearing performance and experience and/or usability of the hearing aids and accessories. Both laboratory measurements as well as evaluations in real life environments will be carried out. This will be a controlled 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 Measurement and Fitting Methods to Determine Their Reliability, Validity and Application

Conditions
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Hearing Loss

Intervention / Treatment
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* Device: Hearing aid: Phonak Audéo B90-Direct


Participation Criteria
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Eligibility Criteria
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Participants fulfilling all of the following inclusion criteria are eligible for the study: Adult hearing impaired persons (minimum age: 18 years) with and without (experience with) hearing aids Healthy outer ear (without previous surgical procedures) Ability to fill in a questionnaire (p/eCRF) conscientiously Informed Consent as documented by signature The presence of any one of the following exclusion criteria will lead to exclusion of the participant: 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 appointments Limited ability to describe listening impressions or to use hearing aids/ accessories Inability to produce a reliable hearing test result Massively limited dexterity Known psychological problems Known central hearing disorders

Ages Eligible for Study
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Minimum Age: 18 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: Single Group Assignment
Interventional Model Description: All participants will receive a hearing aid fitted with fitting method A and afterwards fitted with fitting method B.
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Audéo B-Direct fitted with fitting method A<br>Traditional standard fitting method which do not include adjustments from the participants. | Device: Hearing aid: Phonak Audéo B90-Direct<br>* Hearing aids will be fitted to the participants individual hearing loss.<br>|
| Experimental: Audéo B-Direct fitted with fitting method B<br>Alternative fitting method which includes additional adjustments from the participants. | Device: Hearing aid: Phonak Audéo B90-Direct<br>* Hearing aids will be fitted to the participants individual hearing loss.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Comparison of fitting method A versus B in regard to sound quality | The number of subjects who prefer the hearing aid setting achieved with hearing aid fitting method A versus B will be measured in the lab with the aid of sounds presented via loudspeakers. This will be measured with the Multiple Stimuli with Hidden Reference and Anchor (MUSHRA) method. | 2 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Comparison of fitting method A versus B in regard to speech intelligibility in noise | The speech intelligibility in noise with hearing aid fitting method A versus B will be measured with the aid of the Oldenburg sentence test in dB Speech Reception Treshold (SRT). | 2 months |