Brief Title
Effectiveness of P02 Digital Hearing Aids
Official Title
Effectiveness of NECTEC Model, Body-worn, Digital Hearing Aids and Cost of Screening and Hearing Aids Service in Elders
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 Phase
Phase 1/Phase 2
Study Type
Interventional
Primary Outcome
functional gain
Secondary Outcome
Satisfaction
Condition
Hearing Loss, Bilateral
Intervention
Hearing Aids Evaluation
Study Arms / Comparison Groups
Hearing Aids, Model P02
Description: A body-worn, local made, digital hearing aids Hearing Aids evaluation
Publications
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
Recruitment Information
Recruitment Status
Procedure
Estimated Enrollment
100
Start Date
October 2012
Completion Date
September 2014
Primary Completion Date
September 2014
Eligibility Criteria
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
Gender
All
Ages
60 Years - 90 Years
Accepts Healthy Volunteers
No
Contacts
Kwanchanok Yimtae, MD, ,
Location Countries
Thailand
Location Countries
Thailand
Administrative Informations
NCT ID
NCT01902914
Organization ID
HE551268
Responsible Party
Principal Investigator
Study Sponsor
Khon Kaen University
Study Sponsor
Kwanchanok Yimtae, MD, Principal Investigator, Khon Kaen University
Verification Date
April 2014