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Lab Evaluation of Novel Hearing Aid Coupling Method

Lab Evaluation of Novel Hearing Aid Coupling Method

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05377359
Enrollment
20
Registered
2022-05-17
Start date
2023-02-07
Completion date
2023-11-20
Last updated
2025-03-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hearing Loss

Keywords

Hearing Loss, Hearing Aids, Hearing Aid Receivers

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.

Interventions

DEVICERecordings 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.

DEVICERecordings 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.

DEVICERecordings 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.

DEVICERecordings 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.

Sponsors

Sonova Canada Inc.
CollaboratorINDUSTRY
Western University, Canada
CollaboratorOTHER
Sonova AG
Lead SponsorINDUSTRY

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE

Intervention model description

A single cohort of participants will receive and be assessed in all treatment/intervention conditions

Eligibility

Sex/Gender
ALL
Age
18 Years to 99 Years
Healthy volunteers
Yes

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.

Design outcomes

Primary

MeasureTime frameDescription
Sound Quality Ratings While Streaming60 minutesHearing 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.

Secondary

MeasureTime frameDescription
Situational Preference Ratings60 MinutesHearing aid recordings of different listening situations through different coupling options will be presented via a Multiple Stimuli with Reference and Anchor (MUSHRA) paradigm, where participants will indicate preferences between different recordings. Ratings will be made on a scale where 0 would the minimum value and 100 would be the maximum value. Higher scores indicate increased preferred sound quality. Higher scores will indicate that participants had an increased preference towards that recording when compared to the other recordings. In this measure, on

Countries

Canada

Participant flow

Participants by arm

ArmCount
Participants With Hearing Loss
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.
20
Total20

Baseline characteristics

CharacteristicParticipants With Hearing Loss
Age, Continuous75 Years
Hearing aid experience7.73 years
Hearing Thresholds41 dB HL (decibel Hearing Loss)
Race and Ethnicity Not Collected— Participants
Sex: Female, Male
Female
10 Participants
Sex: Female, Male
Male
10 Participants

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
EG002
affected / at risk
deaths
Total, all-cause mortality
0 / 200 / 200 / 20
other
Total, other adverse events
0 / 200 / 200 / 20
serious
Total, serious adverse events
0 / 200 / 200 / 20

Outcome results

Primary

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.

Time frame: 60 minutes

ArmMeasureGroupValue (MEAN)
Sound Quality RatingsSound Quality Ratings While StreamingVented Domes - Classical - Sharpness57.1 Units on a rating scale
Sound Quality RatingsSound Quality Ratings While StreamingOpen Domes - Pop - Overall Impression43.15 Units on a rating scale
Sound Quality RatingsSound Quality Ratings While StreamingVented Domes - Pop - Overall Impression60.025 Units on a rating scale
Sound Quality RatingsSound Quality Ratings While StreamingState 2 - Pop - Overall Impression64.025 Units on a rating scale
Sound Quality RatingsSound Quality Ratings While StreamingState 1 - Pop - Overall Impression49.00 Units on a rating scale
Sound Quality RatingsSound Quality Ratings While StreamingOpen Domes - Speech - Overall Impression62.9 Units on a rating scale
Sound Quality RatingsSound Quality Ratings While StreamingVented Domes - Speech - Overall Impression68.325 Units on a rating scale
Sound Quality RatingsSound Quality Ratings While StreamingState 2 - Speech - Overall Impression67.575 Units on a rating scale
Sound Quality RatingsSound Quality Ratings While StreamingState 1 - Speech - Overall Impression67.65 Units on a rating scale
Sound Quality RatingsSound Quality Ratings While StreamingOpen Domes - Classical - Overall Impression68.525 Units on a rating scale
Sound Quality RatingsSound Quality Ratings While StreamingVented Domes - Classical - Overall Impression71.775 Units on a rating scale
Sound Quality RatingsSound Quality Ratings While StreamingState 2 - Classical - Overall Impression65.725 Units on a rating scale
Sound Quality RatingsSound Quality Ratings While StreamingState 1 - Classical - Overall Impression61.525 Units on a rating scale
Sound Quality RatingsSound Quality Ratings While StreamingOpen Domes - Pop - Sharpness68.175 Units on a rating scale
Sound Quality RatingsSound Quality Ratings While StreamingVented Domes - Pop - Sharpness55.875 Units on a rating scale
Sound Quality RatingsSound Quality Ratings While StreamingState 2 - Pop - Sharpness49.725 Units on a rating scale
Sound Quality RatingsSound Quality Ratings While StreamingState 1 - Pop - Sharpness57.725 Units on a rating scale
Sound Quality RatingsSound Quality Ratings While StreamingOpen Domes - Classical - Sharpness61.875 Units on a rating scale
Sound Quality RatingsSound Quality Ratings While StreamingState 2 - Classical - Sharpness61.75 Units on a rating scale
Sound Quality RatingsSound Quality Ratings While StreamingState 1 - Classical - Sharpness60.275 Units on a rating scale
Sound Quality RatingsSound Quality Ratings While StreamingOpen Domes - Speech - Sharpness56.95 Units on a rating scale
Sound Quality RatingsSound Quality Ratings While StreamingVented Domes - Speech - Sharpness46.5 Units on a rating scale
Sound Quality RatingsSound Quality Ratings While StreamingState 2 - Speech - Sharpness54.525 Units on a rating scale
Sound Quality RatingsSound Quality Ratings While StreamingState 1 - Speech - Sharpness51.275 Units on a rating scale
Sound Quality RatingsSound Quality Ratings While StreamingOpen Domes - Pop - Fullness45.525 Units on a rating scale
Sound Quality RatingsSound Quality Ratings While StreamingVented Domes - Pop - Fullness61.525 Units on a rating scale
Sound Quality RatingsSound Quality Ratings While StreamingState 2 - Pop - Fullness66.55 Units on a rating scale
Sound Quality RatingsSound Quality Ratings While StreamingState 1 - Pop - Fullness51.725 Units on a rating scale
Sound Quality RatingsSound Quality Ratings While StreamingOpen Domes - Classical - Fullness60.8 Units on a rating scale
Sound Quality RatingsSound Quality Ratings While StreamingVented Domes - Classical - Fullness67.125 Units on a rating scale
Sound Quality RatingsSound Quality Ratings While StreamingState 2 - Classical - Fullness58.425 Units on a rating scale
Sound Quality RatingsSound Quality Ratings While StreamingState 1 - Classical - Fullness59.025 Units on a rating scale
Sound Quality RatingsSound Quality Ratings While StreamingOpen Domes - Speech - Fullness57.875 Units on a rating scale
Sound Quality RatingsSound Quality Ratings While StreamingVented Domes - Speech - Fullness64.1 Units on a rating scale
Sound Quality RatingsSound Quality Ratings While StreamingState 2 - Speech - Fullness60.3 Units on a rating scale
Sound Quality RatingsSound Quality Ratings While StreamingState 1 - Speech - Fullness59.875 Units on a rating scale
Secondary

Situational Preference Ratings

Hearing aid recordings of different listening situations through different coupling options will be presented via a Multiple Stimuli with Reference and Anchor (MUSHRA) paradigm, where participants will indicate preferences between different recordings. Ratings will be made on a scale where 0 would the minimum value and 100 would be the maximum value. Higher scores indicate increased preferred sound quality. Higher scores will indicate that participants had an increased preference towards that recording when compared to the other recordings. In this measure, on

Time frame: 60 Minutes

Population: This is a single arm study, where the arm is participants with hearing loss and who are exposed to multiple interventions (i.e., open domes, closed domes, state 1, and state 2) within-subjects design.

ArmMeasureGroupValue (MEAN)
Sound Quality RatingsSituational Preference RatingsState 2 - Mic Off - Music - Stream82.225 Units on a rating scale
Sound Quality RatingsSituational Preference RatingsState 2 - Mic On - Music - Stream23.125 Units on a rating scale
Sound Quality RatingsSituational Preference RatingsState 1 - Mic Off - Music - Stream50.35 Units on a rating scale
Sound Quality RatingsSituational Preference RatingsState 1 - Mic On - Music - Stream21.95 Units on a rating scale
Sound Quality RatingsSituational Preference RatingsState 2 - Mic Off - Speech - Stream84.225 Units on a rating scale
Sound Quality RatingsSituational Preference RatingsState 2 - Mic On - Speech - Stream29.2 Units on a rating scale
Sound Quality RatingsSituational Preference RatingsState 1 - Mic Off - Speech - Stream63.175 Units on a rating scale
Sound Quality RatingsSituational Preference RatingsState 1 - Mic On - Speech - Stream28.925 Units on a rating scale
Sound Quality RatingsSituational Preference RatingsState 2 - Mic Off - Music - Noise37.6 Units on a rating scale
Sound Quality RatingsSituational Preference RatingsState 2 - Mic On - Music - Noise42.55 Units on a rating scale
Sound Quality RatingsSituational Preference RatingsState 1 - Mic Off - Music - Noise45.90 Units on a rating scale
Sound Quality RatingsSituational Preference RatingsState 1 - Mic On - Music - Noise43.675 Units on a rating scale
Sound Quality RatingsSituational Preference RatingsState 2 - Mic Off - Speech - Noise43.1 Units on a rating scale
Sound Quality RatingsSituational Preference RatingsState 2 - Mic On - Speech - Noise41.675 Units on a rating scale
Sound Quality RatingsSituational Preference RatingsState 1 - Mic Off - Speech - Noise51.225 Units on a rating scale
Sound Quality RatingsSituational Preference RatingsState 1 - Mic On - Speech - Noise39.625 Units on a rating scale

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026