Effectiveness of NECTEC Model, Body-worn, Digital Hearing Aids and Cost of Screening and Hearing Aids Service in Elders
Trial Snapshot
- Phase
- Phase 1
- Sponsor
- Khon Kaen University
- Enrollment
- 100
- Locations
- 1
- Primary Endpoint
- functional gain
Study Overview
Brief Summary
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
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Health Services Research
- Masking
- Double (Participant, Outcomes Assessor)
Eligibility Criteria
- Ages
- 60 Years to 90 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Arms & Interventions
Hearing Aids, Model P02
A body-worn, local made, digital hearing aids Hearing Aids evaluation
Intervention: Hearing Aids Evaluation (Procedure)
Other hearing aids
Other Hearing Aids, Hearing Aids Evaluation
Intervention: Hearing Aids Evaluation (Procedure)
Outcomes
Primary Outcomes
functional gain
Time Frame: Immediate after hearing aids fitting
Different of hearing threshold between aids and un-aids
Secondary Outcomes
- Satisfaction(immediate after hearing aids fitting)
Investigators
Kwanchanok Yimtae, M.D.
Assoc. Prof. Kwanchanok Yimtae
Khon Kaen University