Effectiveness of P02 Digital Hearing Aids

Sensorineural Hearing Loss Clinical Trial

— P02  

Official title:

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

Clinical Trial Details — Status: Unknown status

Administrative data

• NCT number: NCT01902914
• Other study ID #: HE551268
• Status: Unknown status
• Phase: Phase 1/Phase 2
• First received: October 1, 2012
• Last updated: April 17, 2014
• Start date: October 2012
• Est. completion date: September 2014

Study information

• Verified date: April 2014
• Source: Khon Kaen University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Unknown status
• Enrollment: 100
• Est. completion date: September 2014
• Est. primary completion date: September 2014
• Accepts healthy volunteers: No
• Gender: All
• Age group: 60 Years to 90 Years

Eligibility

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

Related Conditions & MeSH terms

• Deafness
• Hearing Loss
• Hearing Loss, Bilateral
• Hearing Loss, Sensorineural
• Sensorineural Hearing Loss

Intervention

Procedure:
• Hearing Aids Evaluation
Functional Gain Sound field Speech Audiometry

Locations

Country	Name	City	State
Thailand	Phu Wieng district	Khon Kaen

Sponsors (1)

Lead Sponsor	Collaborator
Khon Kaen University

Country where clinical trial is conducted

Thailand, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	functional gain	Different of hearing threshold between aids and un-aids	Immediate after hearing aids fitting
Secondary	Satisfaction	Sound quality satisfaction	immediate after hearing aids fitting