NCT04048187

Quality Control of CE-Certified Phonak Hearing Aids - 2019_23

• Status: Withdrawn
• Phase: N/A
• Study type: Interventional
• Enrollment: 0 (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, feasibiltiy 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 interpendency 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 pre-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 prove the overall performance and system context of the functionality in the mobile application in combination with hearing devices under real life conditions with experienced hearing aid users. The enduser should be able to adjust their hearing aid settings by App. The app allows the user to change e.g. the loudness of the hearing aids and to create hearing scenarios by themselves. The users also shall be able to accept a conferecene call, which they will receive from the investigator via App. 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	Phone Application	Phone application is developed to adjust hearing aids. It incorporates functionalities like volume control and program change.

Timeline

• Start date: 2019-08-20
• Primary completion: 2019-09-06
• Completion: 2019-09-06
• First posted: 2019-08-07
• Last updated: 2019-09-20

Locations

1 site across 1 country: Switzerland