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

Primary Purpose

Hearing Loss

Status
Completed
Phase
Not Applicable
Locations
Switzerland
Study Type
Interventional
Intervention
Feature for noise reduction (on)
Feature for noise reduction (off)
Sponsored by
Sonova AG
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Hearing Loss

Eligibility Criteria

18 Years - 99 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Sonova AG

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Experimental device: Noise reduction on

Experimental device: Noise reduction off

Arm Description

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.

To compare the advantage of the special noise reduction feature the tests will be done additionally with the deactivated feature.

Outcomes

Primary Outcome Measures

Subjective Listening Effort Scaling
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

Subjective Ratings of Speech and Music Samples (Part1: Sound Quality)
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.
Measure of Detection Threshold (in dB) for Soft Sounds
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).
Subjective Ratings of Speech and Music Samples (Part 2: Artefact Perception)
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.

Full Information

First Posted
January 22, 2021
Last Updated
March 1, 2022
Sponsor
Sonova AG
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1. Study Identification

Unique Protocol Identification Number
NCT04723173
Brief Title
Quality Control of CE-Certified Phonak Hearing Aids - 2020_43
Official Title
Quality Control of CE-Certified Phonak Hearing Aids - 2020_43
Study Type
Interventional

2. Study Status

Record Verification Date
August 2021
Overall Recruitment Status
Completed
Study Start Date
December 7, 2020 (Actual)
Primary Completion Date
May 11, 2021 (Actual)
Study Completion Date
June 7, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Sonova AG

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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).
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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hearing Loss

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
Participant
Allocation
Randomized
Enrollment
10 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Experimental device: Noise reduction on
Arm Type
Experimental
Arm Description
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.
Arm Title
Experimental device: Noise reduction off
Arm Type
Active Comparator
Arm Description
To compare the advantage of the special noise reduction feature the tests will be done additionally with the deactivated feature.
Intervention Type
Device
Intervention Name(s)
Feature for noise reduction (on)
Intervention Description
The noise reduction feature shall support the hearing aid user in noisy situations and shall reduce the listening effort.
Intervention Type
Device
Intervention Name(s)
Feature for noise reduction (off)
Intervention Description
To show the advantage of the noise reduction feature there is a comparison without the feature necessary.
Primary Outcome Measure Information:
Title
Subjective Listening Effort Scaling
Description
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.
Time Frame
2 weeks
Secondary Outcome Measure Information:
Title
Subjective Ratings of Speech and Music Samples (Part1: Sound Quality)
Description
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.
Time Frame
4 weeks
Title
Measure of Detection Threshold (in dB) for Soft Sounds
Description
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).
Time Frame
2 weeks
Title
Subjective Ratings of Speech and Music Samples (Part 2: Artefact Perception)
Description
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.
Time Frame
2 week

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
99 Years
Accepts Healthy Volunteers
No
Eligibility 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
Facility Information:
Facility Name
Sonova AG
City
Stäfa
State/Province
Zürich
ZIP/Postal Code
8712
Country
Switzerland

12. IPD Sharing Statement

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

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