Effectiveness of P02 Digital Hearing Aids

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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