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Clinical Trial Details — Status: Withdrawn

Administrative data

NCT number NCT04048187
Other study ID # Sonova2019_23
Secondary ID
Status Withdrawn
Phase N/A
First received
Last updated
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
Health authority
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Status Withdrawn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

Study Design


Related Conditions & MeSH terms


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
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