Hearing Loss, Bilateral or Unilateral
Conditions
Brief summary
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
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.
Interventions
DEVICEHearing aid.
The hearing aid will be fitted to the individual hearing loss of the subject.
Sponsors
Phonak AG, Switzerland
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
18 Years to 90 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Difference of speech intelligibility between devices based on Quest platform and Venture platform for different hearing aid styles | 3 years | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Subjective ratings of speech intelligibility during home trials | 3 years | 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). |
| Subjective ratings of sound quality during home trials | 3 years | 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). |
| Subjective ratings of usability during home trials | 3 years | 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). |
Countries
Switzerland
Outcome results
None listed