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Effectiveness of P02 Digital Hearing Aids (P02)

Primary Purpose

Hearing Loss, Bilateral, Sensorineural Hearing Loss

Status
Unknown status
Phase
Phase 1
Locations
Thailand
Study Type
Interventional
Intervention
Hearing Aids Evaluation
Sponsored by
Khon Kaen University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for Hearing Loss, Bilateral focused on measuring hearing aids, hearing disability, community, hearing aids service

Eligibility Criteria

60 Years - 90 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Phu Wieng districtRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Hearing Aids, Model P02

Other hearing aids

Arm Description

A body-worn, local made, digital hearing aids Hearing Aids evaluation

Other Hearing Aids, Hearing Aids Evaluation

Outcomes

Primary Outcome Measures

functional gain
Different of hearing threshold between aids and un-aids

Secondary Outcome Measures

Satisfaction
Sound quality satisfaction

Full Information

First Posted
October 1, 2012
Last Updated
April 17, 2014
Sponsor
Khon Kaen University
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1. Study Identification

Unique Protocol Identification Number
NCT01902914
Brief Title
Effectiveness of P02 Digital Hearing Aids
Acronym
P02
Official Title
Effectiveness of NECTEC Model, Body-worn, Digital Hearing Aids and Cost of Screening and Hearing Aids Service in Elders
Study Type
Interventional

2. Study Status

Record Verification Date
April 2014
Overall Recruitment Status
Unknown status
Study Start Date
October 2012 (undefined)
Primary Completion Date
September 2014 (Anticipated)
Study Completion Date
September 2014 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Khon Kaen University

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hearing Loss, Bilateral, Sensorineural Hearing Loss
Keywords
hearing aids, hearing disability, community, hearing aids service

7. Study Design

Primary Purpose
Health Services Research
Study Phase
Phase 1, Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
100 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Hearing Aids, Model P02
Arm Type
Experimental
Arm Description
A body-worn, local made, digital hearing aids Hearing Aids evaluation
Arm Title
Other hearing aids
Arm Type
Active Comparator
Arm Description
Other Hearing Aids, Hearing Aids Evaluation
Intervention Type
Procedure
Intervention Name(s)
Hearing Aids Evaluation
Other Intervention Name(s)
Functional Gain
Intervention Description
Functional Gain Sound field Speech Audiometry
Primary Outcome Measure Information:
Title
functional gain
Description
Different of hearing threshold between aids and un-aids
Time Frame
Immediate after hearing aids fitting
Secondary Outcome Measure Information:
Title
Satisfaction
Description
Sound quality satisfaction
Time Frame
immediate after hearing aids fitting

10. Eligibility

Sex
All
Minimum Age & Unit of Time
60 Years
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kwanchanok Yimtae, MD
Organizational Affiliation
Khon Kaen University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Phu Wieng district
City
Khon Kaen
Country
Thailand
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Kwanchanok Yimtae, MD
Phone
6643348396
Email
kwayim@kku.ac.th
First Name & Middle Initial & Last Name & Degree
Kwanchanok Yimtae, MD
First Name & Middle Initial & Last Name & Degree
Panida Thanawirattananit, MA
First Name & Middle Initial & Last Name & Degree
Pornthep Kasemsiri, MD
First Name & Middle Initial & Last Name & Degree
Pipop Siripaopradit, MD
First Name & Middle Initial & Last Name & Degree
Puttaravoot Watanasarp, MD
First Name & Middle Initial & Last Name & Degree
Supawan Laohasiriwong, MD
First Name & Middle Initial & Last Name & Degree
Printaporn KingKaew, M.Sc.
First Name & Middle Initial & Last Name & Degree
Pasin Isarasaena, Ph.D
First Name & Middle Initial & Last Name & Degree
Anukool Noimai, M.Eng

12. IPD Sharing Statement

Citations:
PubMed Identifier
34301203
Citation
Kasemsiri P, Yimtae K, Thanawirattananit P, Israsena P, Noymai A, Laohasiriwong S, Vatanasapt P, Siripaopradith P, Kingkaew P. Effectiveness of a programable body-worn digital hearing aid for older adults in a developing country: a randomized controlled trial with a cross-over design. BMC Geriatr. 2021 Jul 23;21(1):437. doi: 10.1186/s12877-021-02325-4.
Results Reference
derived

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Effectiveness of P02 Digital Hearing Aids

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