Hearing Loss, Bilateral or Unilateral Clinical Trial
Official title:
Structured Post Market Clinical Follow-up (PMCF) to Evaluate the Quality of a New Hearing Aid Product Generation.
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.
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. ;
Intervention Model: Single Group Assignment, Masking: Single Blind (Subject)
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Not yet recruiting |
NCT02545569 -
Evaluation of New Custom Made Hearing Product Technology and Shell Modification
|
N/A |