Effectiveness of P02 Digital Hearing Aids

Study Overview
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Brief Summary
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To test the effectiveness of body-worn, digital hearing aids, model 02 which is developed by the National Electronics and Computer Technology Center, Thailand.

Detailed Description
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Hearing aids distribution and service system are limited accessed in hearing disabled people in developing countries. The local-made, body-worn, digital hearing aids is developed by the National Electronics and Computer Technology Center, Thailand. The effectiveness of this model will be compares with other standard body-worn, hearing aids in community elders. The functional gain, quality of sound, customers' satisfaction, and quality of life (EQ-5D, HHIE, HUI-3, IOI-HA) are main outcomes.The cost of Screening and hearing aids will be also investigated. The validity and reliability of several tools used such as the Thai-Hearing Handicap Inventory for elderly (HHIE) questionnaire, Music Test, Thai-Five Minute Hearing Test, and Khon Kaen Hearing Aids Evaluation are also studied.

Official Title
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Effectiveness of NECTEC Model, Body-worn, Digital Hearing Aids and Cost of Screening and Hearing Aids Service in Elders

Conditions
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Hearing Loss, Bilateral, Sensorineural Hearing Loss

Intervention / Treatment
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* Procedure: Hearing Aids Evaluation


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: older than 60 years bilateral sensorineural hearing loss PTA (0.5-2 KHz) of better ear > 40 DB but <75 dB no deformity of pinna and ear canal new or unexperienced hearing aids user can communicate with Thai or local language Exclusion Criteria: speech discrimination <40% suspected of retrocochlear lesion

Ages Eligible for Study
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Minimum Age: 60 Years
Maximum Age: 90 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Health Services Research
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Hearing Aids, Model P02<br>A body-worn, local made, digital hearing aids Hearing Aids evaluation | Procedure: Hearing Aids Evaluation<br>* Functional Gain Sound field Speech Audiometry<br>* Other names: Functional Gain;|
| Active Comparator: Other hearing aids<br>Other Hearing Aids, Hearing Aids Evaluation | Procedure: Hearing Aids Evaluation<br>* Functional Gain Sound field Speech Audiometry<br>* Other names: Functional Gain;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| functional gain | Different of hearing threshold between aids and un-aids | Immediate after hearing aids fitting | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Satisfaction | Sound quality satisfaction | immediate after hearing aids fitting | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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hearing aids, hearing disability, community, hearing aids service