NCT04187781

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 13 (actual)
• Sponsor: Sonova AG · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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

Interventions

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

Timeline

• Start date: 2019-11-11
• Primary completion: 2020-01-17
• Completion: 2020-01-17
• First posted: 2019-12-05
• Last updated: 2020-03-03

Locations

1 site across 1 country: Switzerland