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

Not Applicable

Withdrawn

• Conditions: Hearing Loss
• Interventions: Device: Phone Application

• Registration Number: NCT04048187
• Lead Sponsor: Sonova AG

Brief 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).

Study Timeline

• Study First Submitted: 2019-08-06
• Study First Submitted QC: 2019-08-06
• Study First Posted: 2019-08-07
• Study Start: 2019-08-20
• Status Verified: 2019-09
• Primary Completion: 2019-09-06
• Study Completion: 2019-09-06
• Last Update Submitted: 2019-09-18
• Last Update Posted: 2019-09-20

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

• experienced hearing aid users (minimum age: 18 years, moderate to moderate/severe hearing loss)
• modern subjects with an affinity to new technology
• willingness and interest in testing Apps
• owning a compatible smartphone
• Healthy outer ear
• willingness to wear behind the ear hearing aids
• Informed Consent as documented by signature

Exclusion Criteria

• the audiogramm is not in the fitting range of the intended hearing aid
• limited mobility and not in the position to attend weekly appointments in Stäfa (Switzerland)
• participant is not able to describe experiences and hearing impressions

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Phone Application	Phone Application	-

Primary Outcome Measures

Name	Time	Method
Successful creation of a Custom Sceario (%)	4 weeks	Endusers of the phoneApp are able to add a custum scenario to the app.
Successful answering of conference call (%)	2 weeks	Endusers of the phoneApp are able to answering the conference call?

Trial Locations

Locations (1)

Sonova AG; 🇨🇭 Stäfa, Switzerland