Hearing Loss
Conditions
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
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.
Sponsors
Study design
Intervention model description
A single cohort of participants will receive and be assessed in all treatment/intervention conditions
Eligibility
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
| Measure | Time frame | Description |
|---|---|---|
| Sound Quality Ratings While Streaming | 60 minutes | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Situational Preference Ratings | 60 Minutes | 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 |
Countries
Canada
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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 |
| Total | 20 |
Baseline characteristics
| Characteristic | Participants With Hearing Loss | — |
|---|---|---|
| Age, Continuous | 75 Years | — |
| Hearing aid experience | 7.73 years | — |
| Hearing Thresholds | 41 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 type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 20 | 0 / 20 | 0 / 20 |
| other Total, other adverse events | 0 / 20 | 0 / 20 | 0 / 20 |
| serious Total, serious adverse events | 0 / 20 | 0 / 20 | 0 / 20 |
Outcome results
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
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| Sound Quality Ratings | Sound Quality Ratings While Streaming | Vented Domes - Classical - Sharpness | 57.1 Units on a rating scale |
| Sound Quality Ratings | Sound Quality Ratings While Streaming | Open Domes - Pop - Overall Impression | 43.15 Units on a rating scale |
| Sound Quality Ratings | Sound Quality Ratings While Streaming | Vented Domes - Pop - Overall Impression | 60.025 Units on a rating scale |
| Sound Quality Ratings | Sound Quality Ratings While Streaming | State 2 - Pop - Overall Impression | 64.025 Units on a rating scale |
| Sound Quality Ratings | Sound Quality Ratings While Streaming | State 1 - Pop - Overall Impression | 49.00 Units on a rating scale |
| Sound Quality Ratings | Sound Quality Ratings While Streaming | Open Domes - Speech - Overall Impression | 62.9 Units on a rating scale |
| Sound Quality Ratings | Sound Quality Ratings While Streaming | Vented Domes - Speech - Overall Impression | 68.325 Units on a rating scale |
| Sound Quality Ratings | Sound Quality Ratings While Streaming | State 2 - Speech - Overall Impression | 67.575 Units on a rating scale |
| Sound Quality Ratings | Sound Quality Ratings While Streaming | State 1 - Speech - Overall Impression | 67.65 Units on a rating scale |
| Sound Quality Ratings | Sound Quality Ratings While Streaming | Open Domes - Classical - Overall Impression | 68.525 Units on a rating scale |
| Sound Quality Ratings | Sound Quality Ratings While Streaming | Vented Domes - Classical - Overall Impression | 71.775 Units on a rating scale |
| Sound Quality Ratings | Sound Quality Ratings While Streaming | State 2 - Classical - Overall Impression | 65.725 Units on a rating scale |
| Sound Quality Ratings | Sound Quality Ratings While Streaming | State 1 - Classical - Overall Impression | 61.525 Units on a rating scale |
| Sound Quality Ratings | Sound Quality Ratings While Streaming | Open Domes - Pop - Sharpness | 68.175 Units on a rating scale |
| Sound Quality Ratings | Sound Quality Ratings While Streaming | Vented Domes - Pop - Sharpness | 55.875 Units on a rating scale |
| Sound Quality Ratings | Sound Quality Ratings While Streaming | State 2 - Pop - Sharpness | 49.725 Units on a rating scale |
| Sound Quality Ratings | Sound Quality Ratings While Streaming | State 1 - Pop - Sharpness | 57.725 Units on a rating scale |
| Sound Quality Ratings | Sound Quality Ratings While Streaming | Open Domes - Classical - Sharpness | 61.875 Units on a rating scale |
| Sound Quality Ratings | Sound Quality Ratings While Streaming | State 2 - Classical - Sharpness | 61.75 Units on a rating scale |
| Sound Quality Ratings | Sound Quality Ratings While Streaming | State 1 - Classical - Sharpness | 60.275 Units on a rating scale |
| Sound Quality Ratings | Sound Quality Ratings While Streaming | Open Domes - Speech - Sharpness | 56.95 Units on a rating scale |
| Sound Quality Ratings | Sound Quality Ratings While Streaming | Vented Domes - Speech - Sharpness | 46.5 Units on a rating scale |
| Sound Quality Ratings | Sound Quality Ratings While Streaming | State 2 - Speech - Sharpness | 54.525 Units on a rating scale |
| Sound Quality Ratings | Sound Quality Ratings While Streaming | State 1 - Speech - Sharpness | 51.275 Units on a rating scale |
| Sound Quality Ratings | Sound Quality Ratings While Streaming | Open Domes - Pop - Fullness | 45.525 Units on a rating scale |
| Sound Quality Ratings | Sound Quality Ratings While Streaming | Vented Domes - Pop - Fullness | 61.525 Units on a rating scale |
| Sound Quality Ratings | Sound Quality Ratings While Streaming | State 2 - Pop - Fullness | 66.55 Units on a rating scale |
| Sound Quality Ratings | Sound Quality Ratings While Streaming | State 1 - Pop - Fullness | 51.725 Units on a rating scale |
| Sound Quality Ratings | Sound Quality Ratings While Streaming | Open Domes - Classical - Fullness | 60.8 Units on a rating scale |
| Sound Quality Ratings | Sound Quality Ratings While Streaming | Vented Domes - Classical - Fullness | 67.125 Units on a rating scale |
| Sound Quality Ratings | Sound Quality Ratings While Streaming | State 2 - Classical - Fullness | 58.425 Units on a rating scale |
| Sound Quality Ratings | Sound Quality Ratings While Streaming | State 1 - Classical - Fullness | 59.025 Units on a rating scale |
| Sound Quality Ratings | Sound Quality Ratings While Streaming | Open Domes - Speech - Fullness | 57.875 Units on a rating scale |
| Sound Quality Ratings | Sound Quality Ratings While Streaming | Vented Domes - Speech - Fullness | 64.1 Units on a rating scale |
| Sound Quality Ratings | Sound Quality Ratings While Streaming | State 2 - Speech - Fullness | 60.3 Units on a rating scale |
| Sound Quality Ratings | Sound Quality Ratings While Streaming | State 1 - Speech - Fullness | 59.875 Units on a rating scale |
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.
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| Sound Quality Ratings | Situational Preference Ratings | State 2 - Mic Off - Music - Stream | 82.225 Units on a rating scale |
| Sound Quality Ratings | Situational Preference Ratings | State 2 - Mic On - Music - Stream | 23.125 Units on a rating scale |
| Sound Quality Ratings | Situational Preference Ratings | State 1 - Mic Off - Music - Stream | 50.35 Units on a rating scale |
| Sound Quality Ratings | Situational Preference Ratings | State 1 - Mic On - Music - Stream | 21.95 Units on a rating scale |
| Sound Quality Ratings | Situational Preference Ratings | State 2 - Mic Off - Speech - Stream | 84.225 Units on a rating scale |
| Sound Quality Ratings | Situational Preference Ratings | State 2 - Mic On - Speech - Stream | 29.2 Units on a rating scale |
| Sound Quality Ratings | Situational Preference Ratings | State 1 - Mic Off - Speech - Stream | 63.175 Units on a rating scale |
| Sound Quality Ratings | Situational Preference Ratings | State 1 - Mic On - Speech - Stream | 28.925 Units on a rating scale |
| Sound Quality Ratings | Situational Preference Ratings | State 2 - Mic Off - Music - Noise | 37.6 Units on a rating scale |
| Sound Quality Ratings | Situational Preference Ratings | State 2 - Mic On - Music - Noise | 42.55 Units on a rating scale |
| Sound Quality Ratings | Situational Preference Ratings | State 1 - Mic Off - Music - Noise | 45.90 Units on a rating scale |
| Sound Quality Ratings | Situational Preference Ratings | State 1 - Mic On - Music - Noise | 43.675 Units on a rating scale |
| Sound Quality Ratings | Situational Preference Ratings | State 2 - Mic Off - Speech - Noise | 43.1 Units on a rating scale |
| Sound Quality Ratings | Situational Preference Ratings | State 2 - Mic On - Speech - Noise | 41.675 Units on a rating scale |
| Sound Quality Ratings | Situational Preference Ratings | State 1 - Mic Off - Speech - Noise | 51.225 Units on a rating scale |
| Sound Quality Ratings | Situational Preference Ratings | State 1 - Mic On - Speech - Noise | 39.625 Units on a rating scale |