Lab Evaluation of Novel Hearing Aid Coupling Method
Primary Purpose
Hearing Loss
Status
Recruiting
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Recordings of Hearing Aids with Open Domes
Recordings of Hearing Aids with Closed Domes
Recordings of Hearing Aids with Novel State 1
Recordings of Hearing Aids with Novel State 2
Sponsored by
About this trial
This is an interventional treatment trial for Hearing Loss focused on measuring Hearing Loss, Hearing Aids, Hearing Aid Receivers
Eligibility Criteria
Inclusion Criteria:
- 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
- Willing to have earmold impressions taken
- 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.
- Willingness to wear different styles of couplings
- Willingness to wear binaural fitting
Exclusion Criteria:
- Contraindications to the medical device (MD) in this study (e.g. known hypersensitivity or allergy to the investigational products)
- 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.
Sites / Locations
- Western University - National Centre for AudiologyRecruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Participants with Hearing Loss
Arm Description
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.
Outcomes
Primary Outcome Measures
Sound Quality Ratings while steaming
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.
Secondary Outcome Measures
Situational preference ratings
Hearing aid recordings of different listening situations through different coupling options will be presented via a MUSHRA paradigm, where participants will indicate preferences between different recordings.
Full Information
NCT ID
NCT05377359
First Posted
May 11, 2022
Last Updated
June 28, 2023
Sponsor
Sonova AG
Collaborators
Sonova Canada Inc., Western University, Canada
1. Study Identification
Unique Protocol Identification Number
NCT05377359
Brief Title
Lab Evaluation of Novel Hearing Aid Coupling Method
Official Title
Lab Evaluation of Novel Hearing Aid Coupling Method
Study Type
Interventional
2. Study Status
Record Verification Date
June 2023
Overall Recruitment Status
Recruiting
Study Start Date
March 1, 2023 (Actual)
Primary Completion Date
November 30, 2023 (Anticipated)
Study Completion Date
November 30, 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Sonova AG
Collaborators
Sonova Canada Inc., Western University, Canada
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
Evaluation of different hearing aid coupling methods including two states of a novel coupling method and two traditional coupling methods.
Detailed Description
An important decision in the fitting of hearing aids is the selection of the coupling method. Examples of coupling options include universal rubber domes and custom earmolds. When selecting a coupling method, the degree of venting must be considered.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hearing Loss
Keywords
Hearing Loss, Hearing Aids, Hearing Aid Receivers
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
A single cohort of participants will receive and be assessed in all treatment/intervention conditions
Masking
None (Open Label)
Allocation
N/A
Enrollment
25 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Participants with Hearing Loss
Arm Type
Experimental
Arm Description
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.
Intervention Type
Device
Intervention Name(s)
Recordings of Hearing Aids with Open Domes
Intervention Description
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.
Intervention Type
Device
Intervention Name(s)
Recordings of Hearing Aids with Closed Domes
Intervention Description
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.
Intervention Type
Device
Intervention Name(s)
Recordings of Hearing Aids with Novel State 1
Intervention Description
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.
Intervention Type
Device
Intervention Name(s)
Recordings of Hearing Aids with Novel State 2
Intervention Description
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.
Primary Outcome Measure Information:
Title
Sound Quality Ratings while steaming
Description
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.
Time Frame
60 minutes
Secondary Outcome Measure Information:
Title
Situational preference ratings
Description
Hearing aid recordings of different listening situations through different coupling options will be presented via a MUSHRA paradigm, where participants will indicate preferences between different recordings.
Time Frame
45 Minutes
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
99 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
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.
Exclusion Criteria:
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Bilal Sheikh, MClSc
Phone
2268083260
Email
bilal.sheikh@sonova.com
First Name & Middle Initial & Last Name or Official Title & Degree
Jonathan Vaisberg, PhD
Phone
9057456785
Email
jonathan.vaisberg@sonova.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jinyu Qian, PhD
Organizational Affiliation
Sonova AG
Official's Role
Principal Investigator
Facility Information:
Facility Name
Western University - National Centre for Audiology
City
London
State/Province
Ontario
ZIP/Postal Code
N6G1H1
Country
Canada
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Susan Scollie, PhD
Phone
519 661-2111
Ext
88948
Email
scollie@nca.uwo.ca
First Name & Middle Initial & Last Name & Degree
Paula Folkeard, AuD
Phone
519 661-2111
Ext
88936
Email
folkeard@nca.uwo.ca
First Name & Middle Initial & Last Name & Degree
Susan Scollie, PhD
First Name & Middle Initial & Last Name & Degree
Paula Folkeard, AuD
First Name & Middle Initial & Last Name & Degree
Hasan Saleh, PhD
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
34369262
Citation
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.
Results Reference
background
PubMed Identifier
16515145
Citation
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.
Results Reference
background
PubMed Identifier
32196353
Citation
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.
Results Reference
background
PubMed Identifier
26879562
Citation
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.
Results Reference
background
PubMed Identifier
3678650
Citation
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.
Results Reference
background
PubMed Identifier
3398490
Citation
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.
Results Reference
background
PubMed Identifier
21278262
Citation
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.
Results Reference
background
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Lab Evaluation of Novel Hearing Aid Coupling Method
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