Hearing Aid Transmitter Performance Study - SRF-366
1 other identifier
interventional
23
1 country
1
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).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Apr 2021
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
February 25, 2021
CompletedFirst Posted
Study publicly available on registry
March 1, 2021
CompletedStudy Start
First participant enrolled
April 26, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 25, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
April 25, 2022
CompletedMarch 28, 2023
April 1, 2021
12 months
February 25, 2021
March 24, 2023
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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)".
2 weeks
Secondary Outcomes (3)
Evaluation of listening effort for different loudspeaker.
2 weeks
Evaluation of sound quality of own voice for different loudspeaker.
2 weeks
Evaluation of sound quality of streamed signals for different loudspeaker
2 weeks
Study Arms (2)
New hearing aid loudspeaker
EXPERIMENTALThe 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.
Standard hearing aid loudspeaker
ACTIVE COMPARATORThe hearing aid loudspeaker is a loudspeaker system with the existing acoustic coupling approach which will be fitted based on the participants' individual ear anatomy.
Interventions
The new hearing aid loudspeaker will be fitted to the participants individual ear anatomy and hearing loss.
The standard hearing aid loudspeaker will be fitted to the participants individual ear anatomy and hearing loss.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Sonova AGlead
Study Sites (1)
National Acoustic Laboratories
Sydney, Australia
Related Links
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Jorge Meijra, PhD
National Acoustic Laboratories
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NON RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Purpose
- TREATMENT
- Intervention Model
- CROSSOVER
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 25, 2021
First Posted
March 1, 2021
Study Start
April 26, 2021
Primary Completion
April 25, 2022
Study Completion
April 25, 2022
Last Updated
March 28, 2023
Record last verified: 2021-04
Data Sharing
- IPD Sharing
- Will not share