Quality Control of CE-Certified Phonak Hearing Aids - 2019_34

Last updated: February 28, 2020
Sponsor: Sonova AG
Overall Status: Completed

Phase

N/A

Condition

Hearing Loss

Hearing Impairment

Deafness

Treatment

N/A

Clinical Study ID

NCT04187781
Sonova2019_34
  • Ages > 18
  • All Genders

Study Summary

Phonak Hearing Devices pass through different development and study phases. At an early stage, feasibility studies are conducted to investigate new algorithms, features and functions in an isolated manner. If the benefit is proven, their performance is then investigated regarding interdependency between all available algorithms, features and functions running in parallel in a hearing aid (pivotal/pre-validation studies) and, resulting from the pre-validation studies, they get optimized. Prior to product launch, the Phonak Hearing Systems get reviewed by a final quality control in terms of clinical trials. This is a validation study, investigating improved algorithms, features, functions and wearing comfort. This will be a clinical investigation which will be conducted mono centric at Sonova AG Headquarters based in Stäfa (Switzerland).

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • experienced hearing aid user

  • severe hearing loss

  • willingness and interest in testing an external microphone healthy outer ear

  • willingness to wear behind the ear hearing aids

  • Informed Consent as documented by signature

Exclusion

Exclusion Criteria:

  • the audiogram is not in the fitting range of the intended hearing aid

  • limited mobility and not in the position to attend weekly appointments in Stäfa (Switzerland)

  • participant is not able to describe experiences and hearing impressions

Study Design

Total Participants: 13
Study Start date:
November 11, 2019
Estimated Completion Date:
January 17, 2020

Study Description

This study will compare two settings of an external microphone under real life conditions with experienced hearing aid users.

The external microphone streams the signal (e.g. speaker) directly into the hearing instrument (HI).

The subject should rate the devices in the lab and after a hometrial. The comfort, regarding to the loudness and the sound quality will be tested with the two settings at home and in the lab. Also the speech intelligibility will be tested in the lab.

This will be a clinical investigation which will be conducted mono centric at Sonova AG Headquarters based in Stäfa (Switzerland).

Connect with a study center

  • Sonova AG

    Stäfa, 8712
    Switzerland

    Site Not Available

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