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Trial details imported from ClinicalTrials.gov

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




Registration number
NCT04774185
Ethics application status
Date submitted
25/02/2021
Date registered
1/03/2021

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
NA
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
Trial website
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

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


What supporting documents are/will be available?




Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results not provided in https://clinicaltrials.gov/study/NCT04774185