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

Hearing Loss Clinical Trial

Official title:

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT04048187
• Other study ID #: Sonova2019_23
• Status: Withdrawn
• Phase: N/A
• Start date: August 20, 2019
• Est. completion date: September 6, 2019

Study information

• Verified date: September 2019
• Source: Sonova AG
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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).

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: September 6, 2019
• Est. primary completion date: September 6, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Hearing Loss

Intervention

Device:
• Phone Application
Phone application is developed to adjust hearing aids. It incorporates functionalities like volume control and program change.

Locations

Country	Name	City	State
Switzerland	Sonova AG	Stäfa

Sponsors (1)

Lead Sponsor	Collaborator
Sonova AG

Country where clinical trial is conducted

Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Successful creation of a Custom Sceario (%)	Endusers of the phoneApp are able to add a custum scenario to the app.	4 weeks
Primary	Successful answering of conference call (%)	Endusers of the phoneApp are able to answering the conference call?	2 weeks