- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04187781
Quality Control of CE-Certified Phonak Hearing Aids - 2019_34
Study Overview
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
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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-
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Stäfa, Switzerland, 8712
- Sonova AG
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
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
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.
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OTHER: external microphone new
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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 (%)
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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.
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6 weeks
|
Subjective rating of natural sounds
Time Frame: 6 weeks
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The subject should rate in the hometrial how natural environmental sounds are with the hearing aids.
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6 weeks
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Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (ACTUAL)
Primary Completion (ACTUAL)
Study Completion (ACTUAL)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ACTUAL)
Study Record Updates
Last Update Posted (ACTUAL)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- Sonova2019_34
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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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