Effectiveness of P02 Digital Hearing Aids

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

Status

UNKNOWN

Phases

Phase 1Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01902914

Acronym

P02

Enrollment

100

Registered

2013-07-18

Start date

2012-10-31

Completion date

2014-09-30

Last updated

2014-04-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hearing Loss, Bilateral, Sensorineural Hearing Loss

Keywords

hearing aids, hearing disability, community, hearing aids service

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.

Interventions

PROCEDUREHearing Aids Evaluation

Functional Gain Sound field Speech Audiometry

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

HEALTH_SERVICES_RESEARCH

Masking

DOUBLE (Subject, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

60 Years to 90 Years

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

Design outcomes

Primary

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

Secondary

Measure	Time frame	Description
Satisfaction	immediate after hearing aids fitting	Sound quality satisfaction

Countries

Thailand

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 14, 2026