Effectiveness of P02 Digital Hearing Aids

NCT ID: NCT01902914

Last Updated: 2014-04-21

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE1/PHASE2

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-10-31

Study Completion Date

2014-09-30

Brief Summary

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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

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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.

Conditions

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Hearing Loss, Bilateral Sensorineural Hearing Loss

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

HEALTH_SERVICES_RESEARCH

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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Hearing Aids, Model P02

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

Group Type EXPERIMENTAL

Hearing Aids Evaluation

Intervention Type PROCEDURE

Functional Gain Sound field Speech Audiometry

Other hearing aids

Other Hearing Aids, Hearing Aids Evaluation

Group Type ACTIVE_COMPARATOR

Hearing Aids Evaluation

Intervention Type PROCEDURE

Functional Gain Sound field Speech Audiometry

Interventions

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Hearing Aids Evaluation

Functional Gain Sound field Speech Audiometry

Intervention Type PROCEDURE

Other Intervention Names

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Functional Gain

Eligibility Criteria

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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
Minimum Eligible Age

60 Years

Maximum Eligible Age

90 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Khon Kaen University

OTHER

Sponsor Role lead

Responsible Party

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Kwanchanok Yimtae, M.D.

Assoc. Prof. Kwanchanok Yimtae

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Kwanchanok Yimtae, MD

Role: PRINCIPAL_INVESTIGATOR

Khon Kaen University

Locations

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Phu Wieng district

Khon Kaen, Changwat Khon Kaen, Thailand

Site Status RECRUITING

Countries

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Thailand

Facility Contacts

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Kwanchanok Yimtae, MD

Role: primary

6643348396

References

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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.

Reference Type DERIVED
PMID: 34301203 (View on PubMed)

Other Identifiers

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HE551268

Identifier Type: -

Identifier Source: org_study_id

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