Hearing Impairment, Sensorineural, Hearing Loss, Sensorineural
Conditions
Brief summary
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
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.
Interventions
DIAGNOSTIC_TESTuAud
Patients will receive hearing aid treatment based on an audiometry obtained with an user-operated automated audiometry procedure
DIAGNOSTIC_TESTTraditional audiometry
Patients will receive hearing aid treatment based on an audiometry obtained with an traditional audiometry procedure
Sponsors
Innovation Fund Denmark
William Demant Fonden
University of Southern Denmark
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Caregiver)
Masking description
The HA fitting procedure will be blinded, so neither the participant, the audiologist, nor the follow up test examiner knows which group the participant belongs to.
Intervention model description
randomised control trial
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| SSQ12 (Speech, Spatial & Qualities of Hearing scale) | 3 months | A questionnaire reflecting the patient's subjective assessment of hearing in everyday life. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| HINT (Hearing In Noise Test) | 3 months | A performance test of patients speech intelligibility in noise. |
Other
| Measure | Time frame | Description |
|---|---|---|
| IOI-HA (International Outcome Inventory for Hearing Aids) | 3 months | A questionnaire regarding the patient's own perception of hearing aid outcome. |
| APHAB (Abbreviated Profile of Hearing Aid Benefit). | 3 months | A questionnaire regarding the patient's own perception of hearing and hearing aid outcome. |
| HINT-U (Hearing In Noise test - under amplification) | 3 months. | A variation of the HINT framework targeting potential under amplification of hearing aid sound level. |
| HINT-O (Hearing In Noise Test - Over amplification) | 3 months. | A variation of the HINT framework targeting potential over amplification of hearing aid sound level. |
Countries
Denmark
Contacts
Primary ContactCarl Pedersen, master's degree
Outcome results
None listed