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

University of Southern Denmark (SDU)

Status: Enrolling

Conditions: Hearing Impairment, Sensorineural; Hearing Loss, Sensorineural

Treatments: Diagnostic Test: uAud; Diagnostic Test: Traditional audiometry

Study type: Interventional

Funder types: Other

Identifiers

NCT05043207

UAUD

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 250 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion criteria

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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250 participants in 2 patient groups

uAud

Experimental group

Description:

Patients which hearing aid is fitted based on the audiometry obtained with user-operated automated audiometry.

Treatment:

Diagnostic Test: uAud

control

Active Comparator group

Description:

Patients which hearing aid is fitted based on the audiometry obtained with traditional audiometry.

Treatment:

Diagnostic Test: Traditional audiometry