Study Results
Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.
View full resultsBasic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
NA
20 participants
INTERVENTIONAL
2023-02-07
2023-11-20
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Evaluation of In-lab Benefit for Speech-in-noise Intelligibility With Device for Adults With Mild to Moderate Hearing Loss
NCT07074769
A Comparison of Hearing Aid Fitting Methods
NCT05376215
Assessment of Novel Sound Changing Principles in Hearing Instruments to Determine Their Application - 2019_20
NCT04018911
Preference Comparisons for Algorithms to Hear Speech
NCT05561335
Assessment of Novel Sound Changing Principles in Hearing Instruments to Determine Their Application - 2018_12
NCT03554577
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Venting refers to an opening in the coupling method to allow for the sound transmission from the tympanic membrane to the external environment. The degree of venting has a significant impact on the hearing aid user's experience. More closed (or more occluded) coupling means the vent is smaller or non-existent. Occluded fittings allow for more low-frequency amplification, which improves hearing aid performance like directionality, noise reduction and streaming sound quality. However, occluded fittings lead to complaints of the occlusion effect, in which users complain of their own voice as sounding "boomy" and can also lead to a build-up of pressure in the ear canal which users may find uncomfortable. To relieve the occlusion effect and pressure build-ups, more vented (sometimes called open) couplings can be used by allowing low-frequency sounds to leave the ear. Despite a degradation in hearing aid outcomes like directionality, noise reduction and streaming sound quality, open fits are typically preferred for speech quality and own-voice perception - at least for hearing aid users with milder losses and near-normal thresholds at low frequencies.
The fact that two coupling options are associated with two different outcomes means that hearing aid practitioners need to make an important trade-off. Either their patient will enjoy the full breadth of the hearing aid's signal processing potential (via a more occluded fit) or their patient will enjoy better own-voice perception and relief of air pressure in the ear canal(via a more open fit). A coupling method that allows for the best of both options is left to be desired.
A recent development in coupling methods has allowed us to take advantage of both open and closed fittings in a single solution. More occluded coupling allows for more low-frequency amplification which improves hearing aid performance in areas such as directionality, noise reduction, and streaming sound quality. Whereas, open coupling options reduces complaints of the occlusion effect and is preferred for speech quality and own-voice perception by hearing aid users with milder losses. This novel coupling method will function as both an open and closed fitting depending on the environment the listener is in. State 1 is dedicated to loud environments where the listener can take advantage of noise management solutions and for streaming so they can enjoy better sound quality. State 2 is dedicated to quieter environments where the listener can enjoy better physical comfort and own-voice naturality.
This novel coupling method should theoretically exploit the benefits of both open and closed coupling methods. This study is designed to see how this novel coupling method compares to traditional domes and how this coupling method performs in various listening situations.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Participants with Hearing Loss
Individuals 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.
Recordings of Hearing Aids with Open Domes
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.
Recordings of Hearing Aids with Closed Domes
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.
Recordings of Hearing Aids with Novel State 1
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.
Recordings of Hearing Aids with Novel State 2
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.
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Recordings of Hearing Aids with Open Domes
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.
Recordings of Hearing Aids with Closed Domes
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.
Recordings of Hearing Aids with Novel State 1
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.
Recordings of Hearing Aids with Novel State 2
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
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* 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.
Exclusion Criteria
* 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.
18 Years
99 Years
ALL
Yes
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Sonova Canada Inc.
INDUSTRY
Western University, Canada
OTHER
Sonova AG
INDUSTRY
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Jinyu Qian, PhD
Role: PRINCIPAL_INVESTIGATOR
Sonova AG
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Western University - National Centre for Audiology
London, Ontario, Canada
Countries
Review the countries where the study has at least one active or historical site.
References
Explore related publications, articles, or registry entries linked to this study.
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.
Kuk 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.
Saleh 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.
Winkler 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.
Cox 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.
Gabrielsson 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.
Vasil-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.
Provided Documents
Download supplemental materials such as informed consent forms, study protocols, or participant manuals.
Document Type: Study Protocol and Statistical Analysis Plan
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
SRF-1082
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.