Effectiveness of P02 Digital Hearing Aids

Phase 1

• Conditions: Hearing Loss, Bilateral; Sensorineural Hearing Loss
• Interventions: Procedure: Hearing Aids Evaluation

• Registration Number: NCT01902914
• Lead Sponsor: Khon Kaen University

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 Timeline

• Study Start: 2012-10
• Study First Submitted: 2012-10-01
• Study First Submitted QC: 2013-07-16
• Study First Posted: 2013-07-18
• Status Verified: 2014-04
• Last Update Submitted: 2014-04-17
• Last Update Posted: 2014-04-21
• Primary Completion: 2014-09
• Study Completion: 2014-09

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 100

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Other hearing aids	Hearing Aids Evaluation	Other Hearing Aids, Hearing Aids Evaluation
Hearing Aids, Model P02	Hearing Aids Evaluation	A body-worn, local made, digital hearing aids Hearing Aids evaluation

Primary Outcome Measures

Name	Time	Method
functional gain	Immediate after hearing aids fitting	Different of hearing threshold between aids and un-aids

Secondary Outcome Measures

Name	Time	Method
Satisfaction	immediate after hearing aids fitting	Sound quality satisfaction

Trial Locations

Locations (1)

Phu Wieng district; 🇹🇭 Khon Kaen, Thailand