NCT02740036

Quality Control of CE-Certified Phonak Hearing Aids - 2016_06

Quality Control of CE-Certified Phonak Hearing Aids

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

Summary

A methodical evaluation of new CE-labelled Phonak Hearing Systems is intended to be conducted on hard of hearing participants to grant quality control prior to product launch. The aim of the investigation series is to ensure zero-defect overall performance of the new hearing systems as well as maximum benefit for the participant with the devices in comparison to previously outstanding Phonak Hearing Systems and to equivalent competitor 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 controlled, single blinded and randomised active comparator clinical evaluation which will be conducted mono centric at Sonova AG Headquarters based in Stäfa (Switzerland).

Conditions

• Hearing Loss

Interventions

Type	Name	Description
DEVICE	Hearing Aid (Successor of Phonak Audéo V90)	Successor of Phonak's Receiver-In-the-Canal (RIC) hearing aid Audéo V90.

Timeline

• Start date: 2016-05-01
• Primary completion: 2016-06-01
• Completion: 2016-07-01
• First posted: 2016-04-15
• Last updated: 2016-07-19

Locations

1 site across 1 country: Switzerland