Hearing Aid Transmitter Performance Study - SRF-366
Primary Purpose
Hearing Loss
Status
Completed
Phase
Not Applicable
Locations
Australia
Study Type
Interventional
Intervention
New hearing aid loudspeaker
Standard hearing aid loudspeaker
Sponsored by
About this trial
This is an interventional treatment trial for Hearing Loss focused on measuring Acoustical Coupling
Eligibility Criteria
Inclusion Criteria:
- Adult hearing impaired persons (minimum age: 18 years, mild to moderate Hearing loss)
- Good written and spoken English language skills
- Healthy outer ear
- Ability to fill in a questionnaire (p/eCRF) conscientiously
- Willingness to wear Receiver in Canal hearing aids
- Informed Consent as documented by signature
- Normal cognitive abilities
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 Sydney (AUS)
- 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
- National Acoustic Laboratories
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
New hearing aid loudspeaker
Standard hearing aid loudspeaker
Arm Description
The new hearing aid loudspeaker is a loudspeaker system with a modified acoustic coupling approach which will be fitted based on the participants' individual ear anatomy.
The hearing aid loudspeaker is a loudspeaker system with the existing acoustic coupling approach which will be fitted based on the participants' individual ear anatomy.
Outcomes
Primary Outcome Measures
Evaluation of speech intelligibility and sound quality for different loudspeaker
The Primary Outcome measure of this study is the comparison of the standard hearing aid loudspeaker with the modified one in regard to speech intelligibility in a noisy environment and sound quality in a quiet situation.
The speech intelligibility will be measured using a speech test in dB SRT and the sound quality will be assessed by subjective rating, using percentage of satisfaction from "very satisfied (100)" to "very unsatisfied (0)".
Secondary Outcome Measures
Evaluation of listening effort for different loudspeaker.
The Secondary Outcome measure of this study is the comparison of the standard hearing aid loudspeaker with the modified one in regard to listening effort in a noisy environment.
The listening effort of speech will be assessed by subjective rating, within 13 steps, from "not effortful at all" to "only noise".
Evaluation of sound quality of own voice for different loudspeaker.
The Secondary Outcome measure of this study is the comparison of the standard hearing aid loudspeaker with the modified one in regard to sound quality in quiet.
The sound quality of own voice will be assessed by subjective rating, using percentage of satisfaction from "very satisfied (100)" to "very unsatisfied (0)".
Evaluation of sound quality of streamed signals for different loudspeaker
The Secondary Outcome measure of this study is the comparison of the standard hearing aid loudspeaker with the modified one in regard to sound quality of a streamed signal in quiet and noise..
The sound quality of the streamed signal will be assessed by subjective rating, using percentage of satisfaction from "very satisfied (100)" to "very unsatisfied (0)".
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04774185
Brief Title
Hearing Aid Transmitter Performance Study - SRF-366
Official Title
Hearing Aid Transmitter Performance Study - SRF-366
Study Type
Interventional
2. Study Status
Record Verification Date
April 2021
Overall Recruitment Status
Completed
Study Start Date
April 26, 2021 (Actual)
Primary Completion Date
April 25, 2022 (Actual)
Study Completion Date
April 25, 2022 (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
Data Monitoring Committee
No
5. Study Description
Brief Summary
Sonova 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 Sonova Hearing Systems undergo a final quality control in terms of clinical trials. This is a confirmatory study, investigating benefits of a modified hearing aid loudspeaker. This will be a clinical investigation which will be conducted mono centric at National Acoustic Laboratories a well known institution with exceptional experience (Australia).
Detailed Description
In this study a comparison with two Phonak Receiver in Canal (RIC) devices is done. The experimental device with a modified hearing aid loudspeaker concept and the active comparator with the existing technology will be compared regarding speech intelligibility, listening effort and sound quality in speech in noise, quiet situations for people with mild to moderate hearing losses.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hearing Loss
Keywords
Acoustical Coupling
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
Participant
Allocation
Non-Randomized
Enrollment
23 (Actual)
8. Arms, Groups, and Interventions
Arm Title
New hearing aid loudspeaker
Arm Type
Experimental
Arm Description
The new hearing aid loudspeaker is a loudspeaker system with a modified acoustic coupling approach which will be fitted based on the participants' individual ear anatomy.
Arm Title
Standard hearing aid loudspeaker
Arm Type
Active Comparator
Arm Description
The hearing aid loudspeaker is a loudspeaker system with the existing acoustic coupling approach which will be fitted based on the participants' individual ear anatomy.
Intervention Type
Device
Intervention Name(s)
New hearing aid loudspeaker
Intervention Description
The new hearing aid loudspeaker will be fitted to the participants individual ear anatomy and hearing loss.
Intervention Type
Device
Intervention Name(s)
Standard hearing aid loudspeaker
Intervention Description
The standard hearing aid loudspeaker will be fitted to the participants individual ear anatomy and hearing loss.
Primary Outcome Measure Information:
Title
Evaluation of speech intelligibility and sound quality for different loudspeaker
Description
The Primary Outcome measure of this study is the comparison of the standard hearing aid loudspeaker with the modified one in regard to speech intelligibility in a noisy environment and sound quality in a quiet situation.
The speech intelligibility will be measured using a speech test in dB SRT and the sound quality will be assessed by subjective rating, using percentage of satisfaction from "very satisfied (100)" to "very unsatisfied (0)".
Time Frame
2 weeks
Secondary Outcome Measure Information:
Title
Evaluation of listening effort for different loudspeaker.
Description
The Secondary Outcome measure of this study is the comparison of the standard hearing aid loudspeaker with the modified one in regard to listening effort in a noisy environment.
The listening effort of speech will be assessed by subjective rating, within 13 steps, from "not effortful at all" to "only noise".
Time Frame
2 weeks
Title
Evaluation of sound quality of own voice for different loudspeaker.
Description
The Secondary Outcome measure of this study is the comparison of the standard hearing aid loudspeaker with the modified one in regard to sound quality in quiet.
The sound quality of own voice will be assessed by subjective rating, using percentage of satisfaction from "very satisfied (100)" to "very unsatisfied (0)".
Time Frame
2 weeks
Title
Evaluation of sound quality of streamed signals for different loudspeaker
Description
The Secondary Outcome measure of this study is the comparison of the standard hearing aid loudspeaker with the modified one in regard to sound quality of a streamed signal in quiet and noise..
The sound quality of the streamed signal will be assessed by subjective rating, using percentage of satisfaction from "very satisfied (100)" to "very unsatisfied (0)".
Time Frame
2 weeks
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, mild to moderate Hearing loss)
Good written and spoken English language skills
Healthy outer ear
Ability to fill in a questionnaire (p/eCRF) conscientiously
Willingness to wear Receiver in Canal hearing aids
Informed Consent as documented by signature
Normal cognitive abilities
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 Sydney (AUS)
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jorge Meijra, PhD
Organizational Affiliation
National Acoustic Laboratories
Official's Role
Principal Investigator
Facility Information:
Facility Name
National Acoustic Laboratories
City
Sydney
Country
Australia
12. IPD Sharing Statement
Plan to Share IPD
No
Links:
URL
http://www.phonak.com/en-int/professionals/guides/evidence-library
Description
ActiveVent™ Receiver provides benefit of open and --closed acoustics for better speech understanding in noise and naturalness of own voice perception
Learn more about this trial
Hearing Aid Transmitter Performance Study - SRF-366
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