Effectiveness of P02 Digital Hearing Aids (P02)

April 17, 2014 updated by: Kwanchanok Yimtae, M.D., Khon Kaen University

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

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

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Anticipated)

100

Phase

  • Phase 2
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Thailand
      • Khon Kaen, Thailand
        • Recruiting
        • Phu Wieng district
        • Contact:
        • Principal Investigator:
          • Kwanchanok Yimtae, MD
        • Sub-Investigator:
          • Panida Thanawirattananit, MA
        • Sub-Investigator:
          • Pornthep Kasemsiri, MD
        • Sub-Investigator:
          • Pipop Siripaopradit, MD
        • Sub-Investigator:
          • Puttaravoot Watanasarp, MD
        • Sub-Investigator:
          • Supawan Laohasiriwong, MD
        • Sub-Investigator:
          • Printaporn KingKaew, M.Sc.
        • Sub-Investigator:
          • Pasin Isarasaena, Ph.D
        • Sub-Investigator:
          • Anukool Noimai, M.Eng

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

60 years to 90 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Hearing Aids, Model P02
A body-worn, local made, digital hearing aids Hearing Aids evaluation
Procedure: Hearing Aids Evaluation
Functional Gain Sound field Speech Audiometry
Other Names:
  • Functional Gain
Active Comparator: Other hearing aids
Other Hearing Aids, Hearing Aids Evaluation
Procedure: Hearing Aids Evaluation
Functional Gain Sound field Speech Audiometry
Other Names:
  • Functional Gain

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Khon Kaen University

Investigators

  • Principal Investigator: Kwanchanok Yimtae, MD, Khon Kaen University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2012

Primary Completion (Anticipated)

September 1, 2014

Study Completion (Anticipated)

September 1, 2014

Study Registration Dates

First Submitted

October 1, 2012

First Submitted That Met QC Criteria

July 16, 2013

First Posted (Estimate)

July 18, 2013

Study Record Updates

Last Update Posted (Estimate)

April 21, 2014

Last Update Submitted That Met QC Criteria

April 17, 2014

Last Verified

April 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HE551268

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Sensorineural Hearing Loss

Clinical Trials on Hearing Aids Evaluation

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Panama

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe