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

NCT ID: NCT04187781

Last Updated: 2020-03-03

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 13 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-11-11
• Study Completion Date: 2020-01-17

Brief 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).

Detailed 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).

Conditions

Hearing Loss

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: OTHER
• Blinding Strategy: SINGLE

Study Groups

external microphone old

Group Type: OTHER

external microphone

Intervention Type: DEVICE

External microphone is developed for direct transmission of speech into the hearing aids for better speech intelligibility, especially in noise.

external microphone new

Group Type: OTHER

external microphone

Intervention Type: DEVICE

External microphone is developed for direct transmission of speech into the hearing aids for better speech intelligibility, especially in noise.

Interventions

external microphone

External microphone is developed for direct transmission of speech into the hearing aids for better speech intelligibility, especially in noise.

Intervention Type: DEVICE

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Sonova AG

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Sonova AG

Stäfa, , Switzerland

Countries

Switzerland

Other Identifiers

Sonova2019_34

Identifier Type: -

Identifier Source: org_study_id