NCT03253003

Quality Control of CE-Certified Phonak Hearing Aids - 2017_27

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 19 (actual)
• Sponsor: Sonova AG · Industry
• Sex: All
• Age: 18 Years – 99 Years
• Healthy volunteers: Not accepted

Summary

A methodical evaluation of new CE-labelled Phonak Hearing Systems is intended to be conducted on hard of participants with a hearing loss to grant quality control prior to product launch. The aim of the investigation series is to ensure a stable overall performance of the new hearing systems, a good sound quality during phone calls as well as maximum benefit for the participant with the devices.

Detailed description

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 in the way as planned for this study ("phase of final inspection"). This will be a clinical evaluation which will be conducted mono centric at Sonova AG Headquarters based in Stäfa (Switzerland).

Conditions

• Hearing Loss, Bilateral Sensorineural, Progressive

Interventions

Type	Name	Description
DEVICE	Line extension of the Phonak Audéo B product family	The line extension of Phonak Audéo B product family will be fitted to the participants individual hearing loss.

Timeline

• Start date: 2017-08-07
• Primary completion: 2017-08-25
• Completion: 2017-08-25
• First posted: 2017-08-17
• Last updated: 2017-09-25

Locations

1 site across 1 country: Switzerland