Performance of a Hearing Aid Platform Including Different Styles of Hearing Aids

Study Overview
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Brief Summary
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The reason for this study is to evaluate a new hearing aid product generation replacing the one on the market. The goal is to evaluate the audiological performance, usability as well as features and functions.

Detailed Description
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This is a controlled, single blinded comparative study which is conducted monocentric at Phonak Headquarters in Staefa. The focus is to compare a new hearing aid product generation with the one on the market as well as with competitor devices regarding the audiological performance, usability as well as features and functions with the aid of 382 mild to profound hearing impaired subjects (18-90 yrs). The subjects, all of them native (Swiss) German speakers, individually conduct a number of laboratory standard tests and home trials (questionnaires) during nine weeks including weekly appointments of 2 hours.

Official Title
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Structured Post Market Clinical Follow-up (PMCF) to Evaluate the Quality of a New Hearing Aid Product Generation.

Conditions
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Hearing Loss, Bilateral or Unilateral

Intervention / Treatment
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* Device: Hearing aid.


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: all kinds of hearing loss (sensorineural, conductive, combined) all kinds of hearing loss (flat, sloping) which are in the fitting range of the hearing aids mother tongue (swiss) german Exclusion Criteria: Subjects with a reduced mobility unable to attend weekly study appointments without access to a number of different hearing situations with strongly reduced ability to describe auditory impressions and the usage of the hearing aids which are uncooperative so that it is not possible to record a valid pure tone audiogram with a strongly reduced dexterity with psychological problems central hearing disorders

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 90 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

Intervention Model: Single Group Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Hearing aid<br>172 subjects with a mild hearing loss. 140 subjects with a moderate hearing loss. 70 subjects with a severe/ profound hearing loss. | Device: Hearing aid.<br>* The hearing aid will be fitted to the individual hearing loss of the subject.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Difference of speech intelligibility between devices based on Quest platform and Venture platform for different hearing aid styles | For the objective measurements in laboratory situation, both a standard German speech sentence test in noise (SRT in dB) and a standard German monosyllable word test in quiet (speech discrimination in percent) are used to compare the speech intelligibility for both platforms. The results of the Venture platform of both tests should be at least the same or better than with the Quest platform. | 3 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Subjective ratings of speech intelligibility during home trials | For the subjective rating of speech intelligibility, questionnaires are used to compare the current platform Quest with the new platform Venture. The subjective impressions are rated by rating scales (e.g. Speech intelligibility in quiet: everything - most - half - little - nothing). | 3 years | 
| Subjective ratings of sound quality during home trials | For the subjective rating of sound quality, questionnaires are used to compare the current platform Quest with the new platform Venture. The subjective impressions are rated by rating scales (e.g. Sound quality for speech in quiet: good - dull - sharp - thin - echo - scratchy - unclear - noisy). | 3 years | 
| Subjective ratings of usability during home trials | For the subjective rating of usability, questionnaires are used to compare the current platform Quest with the new platform Venture . The subjective impressions are rated by rating scales (e.g. Rating of the opening and closing of the battery door: very easy - easy - neither - difficult - very difficult). | 3 years |