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

Sonova logo

Sonova

Status

Completed

Conditions

Hearing Loss

Treatments

Device: external microphone

Study type

Interventional

Funder types

Industry

Identifiers

NCT04187781
Sonova2019_34

Details and patient eligibility

About

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).

Full 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).

Enrollment

13 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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 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

Trial design

Primary purpose

Other

Allocation

Randomized

Interventional model

Crossover Assignment

Masking

Single Blind

13 participants in 2 patient groups

external microphone old
Other group
Treatment:
Device: external microphone
external microphone new
Other group
Treatment:
Device: external microphone

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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