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Quality Control of CE-Certified Phonak Hearing Aids - 2020_43

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04723173
Recruitment Status : Completed
First Posted : January 25, 2021
Results First Posted : February 17, 2022
Last Update Posted : March 11, 2022
Sponsor:
Information provided by (Responsible Party):
Sonova AG

Study Description
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Brief Summary:
Phonak Hearing Systems pass through different development and study stages. 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, as a result, they get optimized. Afterwards, and prior to product launch, the Phonak Hearing Systems undergo a final quality control in terms of clinical trials. This is a pre-validation study, investigating optimized 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).

Condition or disease Intervention/treatment Phase
Hearing Loss Device: Feature for noise reduction (on) Device: Feature for noise reduction (off) Not Applicable

Detailed Description:
The study will compare different features of the Phonak behind the ear device activated and deactivated, for example the noise reduction feature. There shall be differences in listening effort, awareness and sound quality shown. The study shall show the advantages especially for people with severe to profound hearing losses. This will be a clinical investigation which will be conducted mono centric at Sonova AG Headquarters based in Stäfa (Switzerland).
Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 10 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single (Participant)
Primary Purpose: Other
Official Title: Quality Control of CE-Certified Phonak Hearing Aids - 2020_43
Actual Study Start Date : December 7, 2020
Actual Primary Completion Date : May 11, 2021
Actual Study Completion Date : June 7, 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Hearing Aids Noise

Arms and Interventions
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Arm Intervention/treatment
Experimental: Experimental device: Noise reduction on
The noise reduction is activated. The feature shall support the hearing aid user in noisy situation and shall reduce the listening effort in these special situations.
 Device: Feature for noise reduction (on)
The noise reduction feature shall support the hearing aid user in noisy situations and shall reduce the listening effort.
Active Comparator: Experimental device: Noise reduction off
To compare the advantage of the special noise reduction feature the tests will be done additionally with the deactivated feature.
 Device: Feature for noise reduction (off)
To show the advantage of the noise reduction feature there is a comparison without the feature necessary.


Outcome Measures
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Primary Outcome Measures :
  1. Subjective Listening Effort Scaling [ Time Frame: 2 weeks ]

    A listening effort scaling procedure ('ACALES'; Krueger et al, 2017) was performed with noise cancellation on and off.

    ACALES is adaptive, altering the signal-to-noise ratio (SNR) at which speech is presented. Therefore it is not a simple rating scale.

    For each stimulus, a rating (14-point scale ranging from 1='effortless' to 14= 'only noise') was given for how "effortful" it was following speech.

    This results in 2-D data: a list of presentation SNRs (different for each participant), and respective participant ratings.

    Given the format of this data, it cannot be summarized using standard descriptive statistics.

    We defined SNR as the dependent variable and fitted a linear mixed effects model, with the predictors: listening effort rating & intervention (treating participants as a random factor), characterizing SNR over the entire rating scale.

    The values reported represent the estimated marginal means of SNR for each intervention, averaged across effort ratings & participants.



Secondary Outcome Measures :
  1. Subjective Ratings of Speech and Music Samples (Part1: Sound Quality) [ Time Frame: 4 weeks ]

    The secondary Outcome measure of this study contains 2 parts. This first part reported here was the evaluation of the sound quality. A comparison was made between speech and music audio excerpts either with or without gain being increased by the feedback manager.

    Subjective ratings of sound quality were made under both of these conditions for one speech and one music sample, using the following scale: Bad (1) - Poor (2) - Fair (3) - Good (4) - Excellent (5).

    Results were analyzed separately for the speech and music samples.


  2. Measure of Detection Threshold (in dB) for Soft Sounds [ Time Frame: 2 weeks ]

    This outcome measure evaluated the ability to detect sounds in a quiet environment.

    A comparison was made between the feature under investigation being activated and deactivated.

    Participants were asked to change the level of a speech sample until they were just able to detect it.

    The ability will be measured by a detection threshold (in dB).


  3. Subjective Ratings of Speech and Music Samples (Part 2: Artefact Perception) [ Time Frame: 2 week ]

    The second part of this secondary Outcome measure was the evaluation of audible artefacts either with or without the available gain being increased by the feedback manager.

    The outcome was measured as a binary response (artefacts audible/ not audible). Participants had to indicate whether artefacts were audible under both of these conditions.

    The number of positive ratings (artefacts were audible) was counted.



Eligibility Criteria
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Ages Eligible for Study:   18 Years to 99 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Adult hearing impaired persons (minimum age: 18 years, severe to profound Hearing loss)
  • Good written and spoken (Swiss) German language skills
  • Healthy outer ear
  • Ability to fill in a questionnaire (p/eCRF) conscientiously
  • willingness to wear Behind-the-ear hearing aids
  • Informed Consent as documented by signature

Exclusion Criteria:

  • Contraindications to the MD in this study, e.g. known hypersensitivity or allergy to the investigational product
  • Limited mobility and not in the position to attend weekly appointments in Stäfa (Switzerland)
  • Limited ability to describe listening impressions/experiences and the use of the hearing aid
  • Inability to produce a reliable hearing test result
  • Known psychological problems
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04723173


Locations
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Switzerland
Sonova AG
Stäfa, Zürich, Switzerland, 8712
Sponsors and Collaborators
Sonova AG
  Study Documents (Full-Text)

Documents provided by Sonova AG:
Study Protocol and Statistical Analysis Plan  [PDF] December 17, 2019

More Information
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Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
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Responsible Party: Sonova AG
ClinicalTrials.gov Identifier: NCT04723173    
Other Study ID Numbers: Sonova2020_43
First Posted: January 25, 2021    Key Record Dates
Results First Posted: February 17, 2022
Last Update Posted: March 11, 2022
Last Verified: August 2021

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Hearing Loss
Hearing Disorders
Ear Diseases
Otorhinolaryngologic Diseases
 Sensation Disorders
Neurologic Manifestations
Nervous System Diseases