Lab Evaluation of Novel Hearing Aid Coupling Method
1 other identifier
interventional
20
1 country
1
Brief Summary
Evaluation of different hearing aid coupling methods including two states of a novel coupling method and two traditional coupling methods.
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 Feb 2023
Shorter than P25 for not_applicable
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
May 11, 2022
CompletedFirst Posted
Study publicly available on registry
May 17, 2022
CompletedStudy Start
First participant enrolled
February 7, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 20, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
November 20, 2023
CompletedResults Posted
Study results publicly available
March 28, 2025
CompletedMarch 28, 2025
February 1, 2024
10 months
May 11, 2022
February 27, 2024
March 10, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Sound Quality Ratings While Streaming
Hearing aid recordings of different coupling options will be presented via a Multiple Stimuli with Reference and Anchor (MUSHRA) paradigm, where participants will rate and compare sound quality attributes between them. Ratings will be made on a scale where 0 would the minimum value and 100 would be the maximum value. Fullness: Higher scores indicate that participants found the recording to be fuller (thicker/richer sound). Higher scores indicate a better outcome. Sharpness: Higher scores indicate that participants found the recording to be sharper (thinner/more shrill). Lower scores indicate a better outcome. Overall Impression: Higher scores indicate that participants had an increased preference towards the recording when compared to the other recordings. Higher scores indicate a better outcome.
60 minutes
Secondary Outcomes (1)
Situational Preference Ratings
60 Minutes
Study Arms (1)
Participants with Hearing Loss
EXPERIMENTALIndividuals with hearing loss that meet the candidacy to wear hearing aids with various coupling methods. All interventions are associated with the fitting of binaural hearing aids with various coupling methods. All participants will be assessed under all interventions.
Interventions
Receiver-in-the-Canal hearing aids will be used which are programmed to the participant's hearing loss and will be coupled to open domes. Recordings will be made of hearing aid output on a head and torso simulator and played back to participants over headphones.
Receiver-in-the-Canal hearing aids will be used which are programmed to the participant's hearing loss and will be coupled with closed domes. Recordings will be made of hearing aid output on a head and torso simulator and played back to participants over headphones.
Receiver-in-the-Canal hearing aids will be used which are programmed to the participant's hearing loss and will be coupled with the new coupling method in its first state. Recordings will be made of hearing aid output on a head and torso simulator and played back to participants over headphones.
Receiver-in-the-Canal hearing aids will be used which are programmed to the participant's hearing loss and will be coupled with the new coupling method in its second state. Recordings will be made of hearing aid output on a head and torso simulator and played back to participants over headphones.
Eligibility Criteria
You may qualify if:
- Hearing aid candidate
- Meets the fitting requirements for novel and traditional coupling options
- Healthy outer ear - no visible congenital or traumatic deformity
- Symmetrical hearing loss
- No air-bone gap greater than 10 dB at 500, 1000, 2000, and 4000 Hz
- Ability to answer questions and repeat sentences
- No history of problematic tinnitus or pain/discomfort from loud sounds
- No history of active drainage from the ears in the past 90 days
- Informed consent as documented by signature.
You may not qualify if:
- Limited mobility (not able to attend scheduled visits)
- Inability to produce reliable hearing test results
- History of active drainage from the ear in the previous 90 days
- Abnormal appearance of the eardrum and ear canal
- Known psychological problems.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Sonova AGlead
- Sonova Canada Inc.collaborator
- Western University, Canadacollaborator
Study Sites (1)
Western University - National Centre for Audiology
London, Ontario, N6G1H1, Canada
Related Publications (7)
Voss SC, Pichora-Fuller MK, Ishida I, Pereira A, Seiter J, El Guindi N, Kuehnel V, Qian J. Evaluating the benefit of hearing aids with motion-based beamformer adaptation in a real-world setup. Int J Audiol. 2022 Aug;61(8):642-654. doi: 10.1080/14992027.2021.1948120. Epub 2021 Aug 7.
PMID: 34369262BACKGROUNDKuk F, Keenan D, Lau CC. Vent configurations on subjective and objective occlusion effect. J Am Acad Audiol. 2005 Oct;16(9):747-62. doi: 10.3766/jaaa.16.9.11.
PMID: 16515145BACKGROUNDSaleh HK, Folkeard P, Macpherson E, Scollie S. Adaptation of the Connected Speech Test: Rerecording and Passage Equivalency. Am J Audiol. 2020 Jun 8;29(2):259-264. doi: 10.1044/2019_AJA-19-00052. Epub 2020 Mar 20.
PMID: 32196353BACKGROUNDWinkler A, Latzel M, Holube I. Open Versus Closed Hearing-Aid Fittings: A Literature Review of Both Fitting Approaches. Trends Hear. 2016 Feb 15;20:2331216516631741. doi: 10.1177/2331216516631741.
PMID: 26879562BACKGROUNDCox RM, Alexander GC, Gilmore C. Development of the Connected Speech Test (CST). Ear Hear. 1987 Oct;8(5 Suppl):119S-126S. doi: 10.1097/00003446-198710001-00010.
PMID: 3678650BACKGROUNDGabrielsson A, Schenkman BN, Hagerman B. The effects of different frequency responses on sound quality judgments and speech intelligibility. J Speech Hear Res. 1988 Jun;31(2):166-77. doi: 10.1044/jshr.3102.166.
PMID: 3398490BACKGROUNDVasil-Dilaj KA, Cienkowski KM. The influence of receiver size on magnitude of acoustic and perceived measures of occlusion. Am J Audiol. 2011 Jun;20(1):61-8. doi: 10.1044/1059-0889(2010/09-0031). Epub 2011 Jan 28.
PMID: 21278262BACKGROUND
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Bilal Sheikh, Research Audiologist
- Organization
- Sonova
Study Officials
- PRINCIPAL INVESTIGATOR
Jinyu Qian, PhD
Sonova AG
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 11, 2022
First Posted
May 17, 2022
Study Start
February 7, 2023
Primary Completion
November 20, 2023
Study Completion
November 20, 2023
Last Updated
March 28, 2025
Results First Posted
March 28, 2025
Record last verified: 2024-02
Data Sharing
- IPD Sharing
- Will not share