Lab Evaluation of Novel Hearing Aid Coupling Method

Study Overview
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Brief Summary
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Evaluation of different hearing aid coupling methods including two states of a novel coupling method and two traditional coupling methods.

Detailed Description
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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.

Official Title
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Lab Evaluation of Novel Hearing Aid Coupling Method

Conditions
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Hearing Loss

Intervention / Treatment
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* 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


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 99 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Interventional Model Description: A single cohort of participants will receive and be assessed in all treatment/intervention conditions
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Participants with Hearing Loss<br>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<br>* 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.<br>Device: Recordings of Hearing Aids with Closed Domes<br>* 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.<br>Device: Recordings of Hearing Aids with Novel State 1<br>* 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.<br>Device: Recordings of Hearing Aids with Novel State 2<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 60 minutes | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 45 Minutes | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Hearing Loss, Hearing Aids, Hearing Aid Receivers