A Study Protocol for the Validation of UAud in a Clinical Setting.

Study Overview
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Brief Summary
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The objective of this study is to validate the User-operated Audiometry (UAud) system for user-operated audiometry in a clinical setting, by investigating if hearing rehabilitation based on UAud is non-inferior to hearing rehabilitation based on traditional audiometry, and whether thresholds obtained with the user-operated version of the Audible Contrast Threshold (ACT) test correlates to traditional measures of speech intelligibility.

Detailed Description
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The project will focus on the initial examination of patients who are referred for hearing aid treatment. This initial examination consists of an audiometry which is currently conducted manually by an audiologist. However, it is possible to conduct an audiometry as a user-operated self-test by using a computer. The project will test if hearing rehabilitation based on the user-operated audiometry is non-inferior to hearing rehabilitation based on the gold standard of manual audiometry. The project will use several types of patient reported measures as well as objective measurements in the clinic. Research of this type is needed to understand if the quality of the hearing aid treatment is equal no matter the type of examination. Also, the study will investigate whether thresholds obtained with the user-operated version of the Audible Contrast Threshold (ACT) test correlates to traditional measures of speech intelligibility.

Official Title
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A Validation of the UAud System for User-operated Audiometry Testing in a Clinical Setting: A Study Protocol for a Blinded Non-inferiority Randomised Controlled Trial.

Conditions
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Hearing Loss, Sensorineural, Hearing Impairment, Sensorineural

Intervention / Treatment
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* Diagnostic Test: uAud
* Diagnostic Test: Traditional audiometry


Participation Criteria
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Eligibility Criteria
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Inclusion criteria Sensorineural hearing loss with hearing thresholds exceeding 20 dB HL at two or more frequencies in the frequency range of 0.5 to 4 kHz. Symmetric hearing loss with a maximum pure-tone average (PTA) (mean of 0.5-1-2-4 kHz) difference between the ears of 15 dB HL. Danish native speaker. No previous experience with HAs. Capable of answering questionnaires through an online mailbox. Exclusion criteria Air-conduction audiometry thresholds exceeding 80 dB HL at two or more frequencies. Treatment affected by conductive hearing loss (air-bone gap >10 dB on more than one frequency below 1 kHz). Conditions with fluctuating hearing loss, e.g., Menière's, on-going treatment with ototoxic drugs. Ear, nose, or throat surgery in the past 12 months. Evidence that the participant has made minor use of the HAs during the study (e.g., < 2h per day). Visual or motor impairment that might affect the use of the UAud system.

Ages Eligible for Study
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Minimum Age: 18 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
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: randomised control trial
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: uAud<br>Patients which hearing aid is fitted based on the audiometry obtained with user-operated automated audiometry. | Diagnostic Test: uAud<br>* Patients will receive hearing aid treatment based on an audiometry obtained with an user-operated automated audiometry procedure<br>|
| Active Comparator: control<br>Patients which hearing aid is fitted based on the audiometry obtained with traditional audiometry. | Diagnostic Test: Traditional audiometry<br>* Patients will receive hearing aid treatment based on an audiometry obtained with an traditional audiometry procedure<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| SSQ12 (Speech, Spatial & Qualities of Hearing scale) | A questionnaire reflecting the patient's subjective assessment of hearing in everyday life. | 3 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| HINT (Hearing In Noise Test) | A performance test of patients speech intelligibility in noise. | 3 months |