An interventional study of Recordings of Hearing Aids with Open Domes and Recordings of Hearing Aids with Closed Domes in Hearing Loss, sponsored by Sonova AG. Completed at 1 site in Canada. Open to participants aged 18 Years to 99 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-03-28.
Sponsored by Sonova AG · Not applicable, Interventional, and Treatment
Evaluation of different hearing aid coupling methods including two states of a novel coupling method and two traditional coupling methods.
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.
1,092 studies on the registry are indexed under Hearing Loss; 235 are open to participants now.
This study's enrollment of 20 is below the median of 40 across 764 interventional studies indexed under Hearing Loss.
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Exclusion Criteria:
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.
Device: Recordings of Hearing Aids with Open Domes · Device: Recordings of Hearing Aids with Closed Domes · Device: Recordings of Hearing Aids with Novel State 1 · Device: 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 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.
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
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
| Milestone | Participants With Hearing Loss |
|---|---|
| Started | 20 |
| Completed | 20 |
| Not completed | 0 |
| Milestone | Participants With Hearing Loss |
|---|---|
| Started | 20 |
| Completed | 20 |
| Not completed | 0 |
| Milestone | Participants With Hearing Loss |
|---|---|
| Started | 20 |
| Completed | 20 |
| Not completed | 0 |
| Milestone | Participants With Hearing Loss |
|---|---|
| Started | 20 |
| Completed | 20 |
| Not completed | 0 |
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.
| Units on a rating scale | Sound Quality Ratings |
|---|---|
| Open Domes - Pop - Overall Impression | 43.15 (1 to 83) |
| Vented Domes - Pop - Overall Impression | 60.025 (17 to 91) |
| State 2 - Pop - Overall Impression | 64.025 (34 to 96) |
| State 1 - Pop - Overall Impression | 49.00 (11 to 91) |
| Open Domes - Speech - Overall Impression | 62.9 (13 to 93) |
| Vented Domes - Speech - Overall Impression | 68.325 (35 to 94) |
| State 2 - Speech - Overall Impression | 67.575 (30 to 95) |
| State 1 - Speech - Overall Impression | 67.65 (23 to 95) |
| Open Domes - Classical - Overall Impression | 68.525 (0 to 94) |
| Vented Domes - Classical - Overall Impression | 71.775 (35 to 94) |
| State 2 - Classical - Overall Impression | 65.725 (35 to 92) |
| State 1 - Classical - Overall Impression | 61.525 (31 to 92) |
| Open Domes - Pop - Sharpness | 68.175 (23 to 93) |
| Vented Domes - Pop - Sharpness | 55.875 (15 to 92) |
| State 2 - Pop - Sharpness | 49.725 (7 to 92) |
| State 1 - Pop - Sharpness | 57.725 (29 to 88) |
| Open Domes - Classical - Sharpness | 61.875 (17 to 95) |
| Vented Domes - Classical - Sharpness | 57.1 (3 to 95) |
| State 2 - Classical - Sharpness | 61.75 (20 to 95) |
| State 1 - Classical - Sharpness | 60.275 (13 to 92) |
| Open Domes - Speech - Sharpness | 56.95 (10 to 93) |
| Vented Domes - Speech - Sharpness | 46.5 (10 to 96) |
| State 2 - Speech - Sharpness | 54.525 (10 to 95) |
| State 1 - Speech - Sharpness | 51.275 (12 to 93) |
| Open Domes - Pop - Fullness | 45.525 (14 to 90) |
| Vented Domes - Pop - Fullness | 61.525 (17 to 95) |
| State 2 - Pop - Fullness | 66.55 (11 to 91) |
| State 1 - Pop - Fullness | 51.725 (30 to 91) |
| Open Domes - Classical - Fullness | 60.8 (0 to 91) |
| Vented Domes - Classical - Fullness | 67.125 (28 to 99) |
| State 2 - Classical - Fullness | 58.425 (26 to 92) |
| State 1 - Classical - Fullness | 59.025 (25 to 91) |
| Open Domes - Speech - Fullness | 57.875 (5 to 93) |
| Vented Domes - Speech - Fullness | 64.1 (23 to 94) |
| State 2 - Speech - Fullness | 60.3 (31 to 93) |
| State 1 - Speech - Fullness | 59.875 (29 to 94) |
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
| Units on a rating scale | Sound Quality Ratings - Situational Preference |
|---|---|
| State 2 - Mic Off - Music - Stream | 82.225 (64 to 100) |
| State 2 - Mic On - Music - Stream | 23.125 (2 to 70) |
| State 1 - Mic Off - Music - Stream | 50.35 (6 to 99) |
| State 1 - Mic On - Music - Stream | 21.95 (2 to 59) |
| State 2 - Mic Off - Speech - Stream | 84.225 (9 to 98) |
| State 2 - Mic On - Speech - Stream | 29.2 (2 to 72) |
| State 1 - Mic Off - Speech - Stream | 63.175 (27 to 98) |
| State 1 - Mic On - Speech - Stream | 28.925 (2 to 72) |
| State 2 - Mic Off - Music - Noise | 37.6 (1 to 99) |
| State 2 - Mic On - Music - Noise | 42.55 (0 to 90) |
| State 1 - Mic Off - Music - Noise | 45.90 (10 to 79) |
| State 1 - Mic On - Music - Noise | 43.675 (1 to 89) |
| State 2 - Mic Off - Speech - Noise | 43.1 (0 to 97) |
| State 2 - Mic On - Speech - Noise | 41.675 (2 to 87) |
| State 1 - Mic Off - Speech - Noise | 51.225 (5 to 96) |
| State 1 - Mic On - Speech - Noise | 39.625 (3 to 73) |
Collected over Participants were exposed to multiple interventions at once and had the ability to cycle through the various interventions (frequency curves). For this reason, adverse event data would have been collected per task and not intervention due to the quick exposure to multiple interventions. Adverse Event Data per participant was collected and is reported below. Streaming sound quality task - 60 minutes Situational preference task - 60 minutes. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Participants With Hearing Loss - Intake and Consent Form | 0/20 (0%) | 0/20 (0%) | 0/20 (0%) |
| Participants With Hearing Loss - Streaming Sound Quality Task | 0/20 (0%) | 0/20 (0%) | 0/20 (0%) |
| Participants With Hearing Loss - Situational Preference Task | 0/20 (0%) | 0/20 (0%) | 0/20 (0%) |
| Age, Continuous(Years) | Participants With Hearing Loss |
|---|---|
| Mean | 75 (61 to 83) |
| Sex: Female, Male(Participants) | Participants With Hearing Loss |
|---|---|
| Female | 10 |
| Male | 10 |
| Race and Ethnicity Not Collected(Participants) | Participants With Hearing Loss |
|---|
| Hearing Thresholds(dB HL (decibel Hearing Loss)) | Participants With Hearing Loss |
|---|---|
| Mean | 41 (25 to 57.5) |
| Hearing aid experience(years) | Participants With Hearing Loss |
|---|---|
| Mean | 7.73 (0 to 27) |
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