ClinicalTrials.Veeva

Menu

Effectiveness of P02 Digital Hearing Aids

K

Khon Kaen University

Status and phase

Unknown
Phase 2
Phase 1

Conditions

Hearing Loss, Bilateral
Sensorineural Hearing Loss

Treatments

Procedure: Hearing Aids Evaluation

Study type

Interventional

Funder types

Other

Identifiers

NCT01902914
HE551268

Details and patient eligibility

About

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

Full 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.

Enrollment

100 estimated patients

Sex

All

Ages

60 to 90 years old

Volunteers

No 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

Trial design

Primary purpose

Health Services Research

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Double Blind

100 participants in 2 patient groups

Hearing Aids, Model P02
Experimental group
Description:
A body-worn, local made, digital hearing aids Hearing Aids evaluation
Treatment:
Procedure: Hearing Aids Evaluation
Other hearing aids
Active Comparator group
Description:
Other Hearing Aids, Hearing Aids Evaluation
Treatment:
Procedure: Hearing Aids Evaluation

Trial contacts and locations

1

Loading...

Data sourced from clinicaltrials.gov

Clinical trials

Find clinical trialsTrials by location
© Copyright 2024 Veeva Systems