Clinical Trial: Performance of a Hearing Aid Platform Including Different Styles of Hearing Aids

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

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

Brief Summary: 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.

Detailed Summary: 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.
Sponsor: Phonak AG, Switzerland

Current Primary Outcome: 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.


Original Primary Outcome: Difference of speech intelligibility between "Bolero Q" and the "Bolero New Generation" of hearing aid [ Time Frame: 4 months ]

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 of the current behind the ear hearing aid ("Bolero Q") with the "Bolero New Generation". The results of both tests measured with the "Bolero New Generation" should be at least the same or better as with "Bolero Q".


Current Secondary Outcome:

  • 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).
  • 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).
  • 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).


Original Secondary Outcome: Subjective ratings of speech intelligibility, sound quality and usability during home trials [ Time Frame: 4 months ]

For the subjective rating of speech intelligibility, sound quality and usability during home trial, questionnaires are used to compare the current behind the ear hearing aid ("Bolero Q") with the "Bolero New Generation". The subjective impressions are rated by rating scales (e.g. Loudness - too loud, loud but comfortable, just right, soft but comfortable, too soft) or direct comparisons. Additionally there is the possibility of free text comments for the subjects. The results of the subjective ratings with the "Bolero New Generation" should be at least the same or better as with "Bolero Q".


Information By: Phonak AG, Switzerland

Dates:
Date Received: November 17, 2014
Date Started: May 2013
Date Completion:
Last Updated: May 2, 2016
Last Verified: May 2016