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| Name | Class |
|---|---|
| Innovation Fund Denmark | INDIV |
| William Demant Fonden | UNKNOWN |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| uAud | Experimental | Patients which hearing aid is fitted based on the audiometry obtained with user-operated automated audiometry. |
|
| control | Active Comparator | Patients which hearing aid is fitted based on the audiometry obtained with traditional audiometry. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| uAud | Diagnostic Test | Patients will receive hearing aid treatment based on an audiometry obtained with an user-operated automated audiometry procedure |
|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| HINT (Hearing In Noise Test) | A performance test of patients speech intelligibility in noise. | 3 months |
| Measure | Description | Time Frame |
|---|---|---|
| IOI-HA (International Outcome Inventory for Hearing Aids) | A questionnaire regarding the patient's own perception of hearing aid outcome. | 3 months |
| APHAB (Abbreviated Profile of Hearing Aid Benefit). |
Inclusion criteria
Exclusion criteria
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Carl Pedersen, master's degree | Contact | +4531314965 | pede@sdu.dk |
| Name | Affiliation | Role |
|---|---|---|
| Jesper Hvass Schmidt, PhD | SDU | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Southern Denmark | Recruiting | Odense | Funen | 5000 | Denmark |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 39620470 | Derived | Pedersen C, Pedersen ER, Laugesen S, Sanchez-Lopez R, Nielsen J, Sorensen CB, Schmidt JH. Comparison of hearing-aid effectiveness based on user-operated versus traditional audiometry: a randomised clinical trial. Int J Audiol. 2026 Feb;65(2):176-183. doi: 10.1080/14992027.2024.2434897. Epub 2024 Dec 2. | |
| 36863737 | Derived |
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Data is governed by the hospital's GPDR (General Data Protection Regulation) agreements.
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| ID | Term |
|---|---|
| D006319 | Hearing Loss, Sensorineural |
| ID | Term |
|---|---|
| D034381 | Hearing Loss |
| D006311 | Hearing Disorders |
| D004427 | Ear Diseases |
| D010038 | Otorhinolaryngologic Diseases |
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randomised control trial
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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.
| Traditional audiometry | Diagnostic Test | Patients will receive hearing aid treatment based on an audiometry obtained with an traditional audiometry procedure |
|
A questionnaire regarding the patient's own perception of hearing and hearing aid outcome.
| 3 months |
| HINT-U (Hearing In Noise test - under amplification) | A variation of the HINT framework targeting potential under amplification of hearing aid sound level. | 3 months. |
| HINT-O (Hearing In Noise Test - Over amplification) | A variation of the HINT framework targeting potential over amplification of hearing aid sound level. | 3 months. |
| Pedersen CC, Pedersen ER, Laugesen S, Sanchez-Lopez R, Nielsen J, Sorensen CB, Sidiras C, Pedersen RG, Schmidt JH. Comparison of hearing aid fitting effectiveness with audiograms from either user-operated or traditional audiometry in a clinical setting: a study protocol for a blinded non-inferiority randomised controlled trial. BMJ Open. 2023 Mar 2;13(3):e065777. doi: 10.1136/bmjopen-2022-065777. |
| D012678 |
| Sensation Disorders |
| D009461 | Neurologic Manifestations |
| D009422 | Nervous System Diseases |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |