NCT03751891

Quality Control of CE-Certified Phonak Hearing Aids - Sonova2018_05

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 15 (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 validation study, investigating optimized algorithms, features, functions and wearing comfort. This will be a clinical evaluation which will be conducted mono centric at Sonova AG Headquarters based in Stäfa (Switzerland).

Detailed description

In this study a comparison with a CE-labeled Phonak Receiver-in-the-canal (RIC) device (active comparator) and two CE-labeled competitor devices (RIC) is done. All study devices contain direct connectivity functionality which will be compared in terms of streamed Audio quality, streaming stability and Usability preferences of all available functions and features. This will be a clinical evaluation which will be conducted mono centric at Sonova AG Headquarters based in Stäfa (Switzerland).

Conditions

• Hearing Loss, Sensorineural

Interventions

Type	Name	Description
DEVICE	Phonak Audéo B90-Direct	The Phonak Audéo B90-Direct is the most recent Receiver-in-the-canal Hearing aid from Phonak which will be fitted to the participants individual Hearing loss.
DEVICE	HearingAid_A	HearingAid\_A is the most recent Receiver-in-the-canal Hearing aid from manufacturer\_A which will be fitted to the participants individual Hearing loss.
DEVICE	HearingAid_B	HearingAid\_B is the most recent Receiver-in-the-canal Hearing aid from manufacturer\_B which will be fitted to the participants individual Hearing loss.

Timeline

• Start date: 2018-03-12
• Primary completion: 2018-04-13
• Completion: 2018-05-31
• First posted: 2018-11-23
• Last updated: 2018-11-23

Locations

1 site across 1 country: Switzerland