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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/NCT04774185




Registration number
NCT04774185
Ethics application status
Date submitted
25/02/2021
Date registered
1/03/2021
Date last updated
28/03/2023

Titles & IDs
Public title
Hearing Aid Transmitter Performance Study - SRF-366
Scientific title
Hearing Aid Transmitter Performance Study - SRF-366
Secondary ID [1] 0 0
SRF-366
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Hearing Loss 0 0
Condition category
Condition code
Ear 0 0 0 0
Deafness

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Devices - New hearing aid loudspeaker
Treatment: Devices - Standard hearing aid loudspeaker

Experimental: New hearing aid loudspeaker - 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.

Active Comparator: Standard hearing aid loudspeaker - 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.


Treatment: Devices: New hearing aid loudspeaker
The new hearing aid loudspeaker will be fitted to the participants individual ear anatomy and hearing loss.

Treatment: Devices: Standard hearing aid loudspeaker
The standard hearing aid loudspeaker will be fitted to the participants individual ear anatomy and hearing loss.
Intervention code [1] 0 0
Treatment: Devices
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Evaluation of speech intelligibility and sound quality for different loudspeaker
Timepoint [1] 0 0
2 weeks
Secondary outcome [1] 0 0
Evaluation of listening effort for different loudspeaker.
Timepoint [1] 0 0
2 weeks
Secondary outcome [2] 0 0
Evaluation of sound quality of own voice for different loudspeaker.
Timepoint [2] 0 0
2 weeks
Secondary outcome [3] 0 0
Evaluation of sound quality of streamed signals for different loudspeaker
Timepoint [3] 0 0
2 weeks

Eligibility
Key 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
Minimum age
18 Years
Maximum age
99 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s


Intervention assignment
Crossover
Other design features
Phase
Not Applicable
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
26/04/2021
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
25/04/2022
Sample size
Target
Accrual to date
Final
23
Recruitment in Australia
Recruitment state(s)
Recruitment hospital [1] 0 0
National Acoustic Laboratories - Sydney
Recruitment postcode(s) [1] 0 0
- Sydney

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
Sonova AG
Address
Country

Ethics approval
Ethics application status

Summary
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 website
https://clinicaltrials.gov/ct2/show/NCT04774185
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Jorge Meijra, PhD
Address 0 0
National Acoustic Laboratories
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/ct2/show/NCT04774185