Investigations of Ear Tip Performance, Perceptions, and Experiences

Study Overview
=================
Brief Summary
-----------------
Normal hearing participants will be fit with a hearing aid and different types of customized earmolds. Hearing aids will be programmed to a simulated mild, flat, sensorineural hearing loss of 30 dB HL from 250-8000Hz. Objective acoustic real ear measures and subjective ratings of sound quality and physical comfort will be evaluated and compared between earmolds. Findings will help researchers to better understand the impacts of different earmolds and how each might affect overall point-of-care.

Official Title
-----------------
Novel Technology Adoption in the Audiology Clinic: Investigations of Ear Tip Performance, Perceptions, and Experiences

Conditions
-----------------
Hearing Aids

Intervention / Treatment
-----------------
* Device: BTE hearing aid with compatible earmolds


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Normal hearing thresholds (<25 dB HL) at octave frequencies from 250-8000Hz. Normal otoscopy: patent ear canals with normal appearing eardrums and aerated middle ear, bilaterally. English as primary spoken language. Exclusion Criteria: history of extensive or current outer or middle ear pathology. history of extensive outer or middle ear surgery. history of neurological or cognitive disorder.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 89 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Third-party control<br>Ear canal impressions will be will be packaged and sent to a professional third-party manufacturer for fabrication in an acrylic material-type. These will serve as the control earmolds, by which the in-house study/intervention earmolds will be compared against. To control for style of earmolds, all earmolds will be made in a skeleton style with a sound bore that accommodates size #13 tubing and a separate select-a-vent (SAV). | Device: BTE hearing aid with compatible earmolds<br>* Hearing aids will be fit with three different types of customized earmolds. They will only wear each earmold group for the duration of the test (total =  2.5 hours). Hearing aids will be programmed to a simulated mild, flat, sensorineural hearing loss of 30 dB HL from 250-8000Hz. A short washout period will follow completion of testing with ear earmold group.<br>|
| Experimental: In-house Study group_Resin<br>Custom earmold impressions will be scanned and edited using computer-aided design software. These 3D earmold meshes will then be converted to g-code using licensed software and sent to a stereolithography 3D printer for fabrication. Participants will only wear these study earmolds for the duration of testing.To control for style of earmolds, all earmolds will be made in a skeleton style with a sound bore that accommodates size #13 tubing and a separate select-a-vent (SAV). | Device: BTE hearing aid with compatible earmolds<br>* Hearing aids will be fit with three different types of customized earmolds. They will only wear each earmold group for the duration of the test (total =  2.5 hours). Hearing aids will be programmed to a simulated mild, flat, sensorineural hearing loss of 30 dB HL from 250-8000Hz. A short washout period will follow completion of testing with ear earmold group.<br>|
| Experimental: In-house Study group_PLA<br>Custom earmold impressions will be scanned and edited using computer-aided design software. These 3D earmold meshes will then be converted to g-code using licensed software and sent to a fused deposition modeling 3D printer for fabrication. Participants will only wear these study earmolds for the duration of testing. To control for style of earmolds, all earmolds will be made in a skeleton style with a sound bore that accommodates size #13 tubing and a separate select-a-vent (SAV). | Device: BTE hearing aid with compatible earmolds<br>* Hearing aids will be fit with three different types of customized earmolds. They will only wear each earmold group for the duration of the test (total =  2.5 hours). Hearing aids will be programmed to a simulated mild, flat, sensorineural hearing loss of 30 dB HL from 250-8000Hz. A short washout period will follow completion of testing with ear earmold group.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Real Ear Measures | Evaluation of ear canal acoustics with participant wearing hearing aid and earmold. A thin microphone tube is placed in the ear canal to measure the average amount of sound across various frequencies (250-8000Hz) while the participant sits in front of a speaker playing sound samples. | 2nd listening session appointment ( 2.5 hours) | 
| Outer Effectiveness of Auditory Rehabilitation (EAR) questionnaire | A questionnaire eliciting patient perception of physical comfort, quality of voice, and overall self-perceived satisfaction. Includes 12 items (5 point) that are scored on a 0 to 100, with 100 representing best possible function/rating | 2nd listening session appointment ( 2.5 hours) | 
| Speech Spatial Qualities (SSQ) questionnaire: | A subsection of this questionnaire,  qualities of hearing, will be administered to evaluate participant's perceptions of acoustic quality and comfort. This subsection includes 18 items (10 points) that are scored on a 0 to 10, with 10 representing best possible function/rating | 2nd listening session appointment ( 2.5 hours) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Physical variables | Physical dimensions of earmolds will be taken using digital calipers. Does not require participants to be present. | Prior to 2nd listening session appointment ( 7-14 days) | 
| Production variables | The total raw cost ($) and time (min) of production will be measured for each earmold group. | Prior to 2nd listening session appointment ( 7-14 days) | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
earmold, hearing aid