NCT04723173

Quality Control of CE-Certified Phonak Hearing Aids - 2020_43

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 10 (actual)
• Sponsor: Sonova AG · Industry
• Sex: All
• Age: 18 Years – 99 Years
• Healthy volunteers: Not accepted

Summary

Phonak Hearing Systems pass through different development and study stages. 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, as a result, they get optimized. Afterwards, and prior to product launch, the Phonak Hearing Systems undergo a final quality control in terms of clinical trials. This is a pre-validation study, investigating optimized 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

The study will compare different features of the Phonak behind the ear device activated and deactivated, for example the noise reduction feature. There shall be differences in listening effort, awareness and sound quality shown. The study shall show the advantages especially for people with severe to profound hearing losses. 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	Feature for noise reduction (on)	The noise reduction feature shall support the hearing aid user in noisy situations and shall reduce the listening effort.
DEVICE	Feature for noise reduction (off)	To show the advantage of the noise reduction feature there is a comparison without the feature necessary.

Timeline

• Start date: 2020-12-07
• Primary completion: 2021-05-11
• Completion: 2021-06-07
• First posted: 2021-01-25
• Last updated: 2022-03-11
• Results posted: 2022-02-17

Locations

1 site across 1 country: Switzerland