Effectiveness of P02 Digital Hearing Aids

This study is currently recruiting participants. (see Contacts and Locations)
Verified April 2014 by Khon Kaen University
Sponsor:
Information provided by (Responsible Party):
Kwanchanok Yimtae, M.D., Khon Kaen University
ClinicalTrials.gov Identifier:
NCT01902914
First received: October 1, 2012
Last updated: April 17, 2014
Last verified: April 2014
  Purpose

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


Condition Intervention Phase
Hearing Loss, Bilateral
Sensorineural Hearing Loss
Procedure: Hearing Aids Evaluation
Phase 1
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Outcomes Assessor)
Primary Purpose: Health Services Research
Official Title: Effectiveness of NECTEC Model, Body-worn, Digital Hearing Aids and Cost of Screening and Hearing Aids Service in Elders

Resource links provided by NLM:


Further study details as provided by Khon Kaen University:

Primary Outcome Measures:
  • functional gain [ Time Frame: Immediate after hearing aids fitting ] [ Designated as safety issue: No ]
    Different of hearing threshold between aids and un-aids


Secondary Outcome Measures:
  • Satisfaction [ Time Frame: immediate after hearing aids fitting ] [ Designated as safety issue: No ]
    Sound quality satisfaction


Estimated Enrollment: 100
Study Start Date: October 2012
Estimated Study Completion Date: September 2014
Estimated Primary Completion Date: September 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 Name: Functional Gain
Active Comparator: Other hearing aids
Other Hearing Aids, Hearing Aids Evaluation
Procedure: Hearing Aids Evaluation
Functional Gain Sound field Speech Audiometry
Other Name: Functional Gain

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.

  Eligibility

Ages Eligible for Study:   60 Years to 90 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01902914

Locations
Thailand
Phu Wieng district Recruiting
Khon Kaen, Thailand
Contact: Kwanchanok Yimtae, MD    6643348396    kwayim@kku.ac.th   
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         
Sponsors and Collaborators
Khon Kaen University
Investigators
Principal Investigator: Kwanchanok Yimtae, MD Khon Kaen University
  More Information

No publications provided

Responsible Party: Kwanchanok Yimtae, M.D., Assoc. Prof. Kwanchanok Yimtae, Khon Kaen University
ClinicalTrials.gov Identifier: NCT01902914     History of Changes
Other Study ID Numbers: HE551268
Study First Received: October 1, 2012
Last Updated: April 17, 2014
Health Authority: Thailand: Khon Kaen University Ethics Committee for Human Research

Keywords provided by Khon Kaen University:
hearing aids
hearing disability
community
hearing aids service

Additional relevant MeSH terms:
Acquired Immunodeficiency Syndrome
Hearing Loss
Deafness
Hearing Loss, Bilateral
Hearing Loss, Sensorineural
HIV Infections
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Slow Virus Diseases
Immunologic Deficiency Syndromes
Immune System Diseases
Hearing Disorders
Ear Diseases
Otorhinolaryngologic Diseases
Sensation Disorders
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms

ClinicalTrials.gov processed this record on July 31, 2014