Quality Control of CE-Certified Phonak Hearing Aids - 2019_34

February 28, 2020 updated by: Sonova AG
Phonak Hearing Devices pass through different development and study phases. At an early stage, feasibility 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 interdependency 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 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).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

This study will compare two settings of an external microphone under real life conditions with experienced hearing aid users.

The external microphone streams the signal (e.g. speaker) directly into the hearing instrument (HI).

The subject should rate the devices in the lab and after a hometrial. The comfort, regarding to the loudness and the sound quality will be tested with the two settings at home and in the lab. Also the speech intelligibility will be tested in the lab.

This will be a clinical investigation which will be conducted mono centric at Sonova AG Headquarters based in Stäfa (Switzerland).

Study Type

Interventional

Enrollment (Actual)

13

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • experienced hearing aid user
  • severe hearing loss
  • willingness and interest in testing an external microphone healthy outer ear
  • willingness to wear behind the ear hearing aids
  • Informed Consent as documented by signature

Exclusion Criteria:

  • the audiogram 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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: OTHER
  • Allocation: RANDOMIZED
  • Interventional Model: CROSSOVER
  • Masking: SINGLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
OTHER: external microphone old
External microphone is developed for direct transmission of speech into the hearing aids for better speech intelligibility, especially in noise.
OTHER: external microphone new
External microphone is developed for direct transmission of speech into the hearing aids for better speech intelligibility, especially in noise.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Rating of the subjective comfort for the old and the new setting
Time Frame: 6 weeks
Rating of the comfort, regarding to the loudness, with the old and the new setting of the external microphone (%)
6 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Evaluation of the speech intelligibility in noise
Time Frame: 2 weeks
Another Outcome measure of this study is the Evaluation of speech understanding in noise of the device with the old setting and the new setting. Speech understanding in noise will be evaluated with an objective and validated test procedure, the Outcome measure will be the speech intelligibility in %.
2 weeks
Subjective Sound Quality rating
Time Frame: 6 weeks
The secondary Outcome measure of this study is the Evaluation of the perceived Sound Quality (rated via subjective satisfaction rating) of the signal with the old setting, compared to the new setting of the external microphone.
6 weeks
Subjective rating of natural sounds
Time Frame: 6 weeks
The subject should rate in the hometrial how natural environmental sounds are with the hearing aids.
6 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

November 11, 2019

Primary Completion (ACTUAL)

January 17, 2020

Study Completion (ACTUAL)

January 17, 2020

Study Registration Dates

First Submitted

December 3, 2019

First Submitted That Met QC Criteria

December 4, 2019

First Posted (ACTUAL)

December 5, 2019

Study Record Updates

Last Update Posted (ACTUAL)

March 3, 2020

Last Update Submitted That Met QC Criteria

February 28, 2020

Last Verified

February 1, 2020

More Information

Terms related to this study

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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