Performance of a Hearing Aid Platform Including Different Styles of Hearing Aids

May 2, 2016 updated by: Phonak AG, Switzerland

Structured Post Market Clinical Follow-up (PMCF) to Evaluate the Quality of a New Hearing Aid Product Generation.

The reason for this study is to evaluate a new hearing aid product generation replacing the one on the market. The goal is to evaluate the audiological performance, usability as well as features and functions.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

This is a controlled, single blinded comparative study which is conducted monocentric at Phonak Headquarters in Staefa. The focus is to compare a new hearing aid product generation with the one on the market as well as with competitor devices regarding the audiological performance, usability as well as features and functions with the aid of 382 mild to profound hearing impaired subjects (18-90 yrs). The subjects, all of them native (Swiss) German speakers, individually conduct a number of laboratory standard tests and home trials (questionnaires) during nine weeks including weekly appointments of 2 hours.

Study Type

Interventional

Enrollment (Actual)

253

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

  • Switzerland
    • Zürich
      • Stäfa, Zürich, Switzerland, 8712
        • Phonak AG

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 to 90 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • all kinds of hearing loss (sensorineural, conductive, combined)
  • all kinds of hearing loss (flat, sloping) which are in the fitting range of the hearing aids
  • mother tongue (swiss) german

Exclusion Criteria:

Subjects

  • with a reduced mobility unable to attend weekly study appointments
  • without access to a number of different hearing situations
  • with strongly reduced ability to describe auditory impressions and the usage of the hearing aids
  • which are uncooperative so that it is not possible to record a valid pure tone audiogram
  • with a strongly reduced dexterity
  • with psychological problems
  • central hearing disorders

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

  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: Hearing aid
172 subjects with a mild hearing loss. 140 subjects with a moderate hearing loss. 70 subjects with a severe/ profound hearing loss.
Device: Hearing aid.
The hearing aid will be fitted to the individual hearing loss of the subject.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Difference of speech intelligibility between devices based on Quest platform and Venture platform for different hearing aid styles
Time Frame: 3 years
For the objective measurements in laboratory situation, both a standard German speech sentence test in noise (SRT in dB) and a standard German monosyllable word test in quiet (speech discrimination in percent) are used to compare the speech intelligibility for both platforms. The results of the Venture platform of both tests should be at least the same or better than with the Quest platform.
3 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Subjective ratings of speech intelligibility during home trials
Time Frame: 3 years
For the subjective rating of speech intelligibility, questionnaires are used to compare the current platform Quest with the new platform Venture. The subjective impressions are rated by rating scales (e.g. Speech intelligibility in quiet: everything - most - half - little - nothing).
3 years
Subjective ratings of sound quality during home trials
Time Frame: 3 years
For the subjective rating of sound quality, questionnaires are used to compare the current platform Quest with the new platform Venture. The subjective impressions are rated by rating scales (e.g. Sound quality for speech in quiet: good - dull - sharp - thin - echo - scratchy - unclear - noisy).
3 years
Subjective ratings of usability during home trials
Time Frame: 3 years
For the subjective rating of usability, questionnaires are used to compare the current platform Quest with the new platform Venture . The subjective impressions are rated by rating scales (e.g. Rating of the opening and closing of the battery door: very easy - easy - neither - difficult - very difficult).
3 years

Collaborators and Investigators

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

Sponsor

Phonak AG, Switzerland

Investigators

  • Principal Investigator: Simone Ebbing, B. Sc., Phonak AG

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

May 1, 2013

Primary Completion (Actual)

August 1, 2015

Study Completion (Actual)

September 1, 2015

Study Registration Dates

First Submitted

November 17, 2014

First Submitted That Met QC Criteria

November 19, 2014

First Posted (Estimate)

November 24, 2014

Study Record Updates

Last Update Posted (Estimate)

May 3, 2016

Last Update Submitted That Met QC Criteria

May 2, 2016

Last Verified

May 1, 2016

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • KEK 2013-0144

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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