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

Primary Purpose

Hearing Loss

Status

Withdrawn

Phase

Not Applicable

Locations

Switzerland

Study Type

Interventional

Intervention

Phone Application

About this trial

This is an interventional other trial for Hearing Loss

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Sonova AG

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Phone Application

Arm Description

Outcomes

Primary Outcome Measures

Successful creation of a Custom Sceario (%)

Endusers of the phoneApp are able to add a custum scenario to the app.

Successful answering of conference call (%)

Endusers of the phoneApp are able to answering the conference call?

Secondary Outcome Measures

Full Information

NCT ID

NCT04048187

First Posted

August 6, 2019

Last Updated

September 18, 2019

Sponsor

Sonova AG

1. Study Identification

Unique Protocol Identification Number

NCT04048187

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

September 2019

Overall Recruitment Status

Withdrawn

Why Stopped

PMCF data, originally planned to be collected withthis study, are collected using another methodology

Study Start Date

August 20, 2019 (Actual)

Primary Completion Date

September 6, 2019 (Actual)

Study Completion Date

September 6, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Sonova AG

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Hearing Loss

7. Study Design

Primary Purpose

Other

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

0 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Phone Application

Arm Type

Experimental

Intervention Type

Device

Intervention Name(s)

Phone Application

Intervention Description

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

Primary Outcome Measure Information:

Title

Successful creation of a Custom Sceario (%)

Description

Endusers of the phoneApp are able to add a custum scenario to the app.

Time Frame

4 weeks

Title

Successful answering of conference call (%)

Description

Endusers of the phoneApp are able to answering the conference call?

Time Frame

2 weeks

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Facility Information:

Facility Name

Sonova AG

City

Stäfa

ZIP/Postal Code

8712

Country

Switzerland

12. IPD Sharing Statement

Learn more about this trial

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

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