Effectiveness of P02 Digital Hearing Aids | NCT01902914

Studies
Effectiveness of P02 Digital Hearing Aids

NCT01902914

Sponsor

Khon Kaen University

Status

Unknown status

Last Update Posted

Apr 21, 2014Estimated

Enrollment

100Estimated

Phase

Phase 1Phase 2

Conditions

Hearing Loss, Bilateral
Sensorineural Hearing Loss

Interventions

Hearing Aids Evaluation

Countries

Thailand

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

Annotation Module

Unposted Annotation

Unposted Responsible Party

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Apr 2014

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Oct 2012

Primary Completion Date

Sep 2014Estimated

Completion Date

Sep 2014Estimated

First Submitted Date

Oct 1, 2012

First Submission Date that Met QC Criteria

Jul 16, 2013

First Posted Date

Jul 18, 2013Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Apr 17, 2014

Last Update Posted Date

Apr 21, 2014Estimated

Sponsor/Collaborators Module

Responsible Party, by Official Title

Kwanchanok Yimtae, M.D., Assoc. Prof. Kwanchanok Yimtae, Khon Kaen UniversityPrincipal Investigator

Lead Sponsor

Khon Kaen UniversityOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 1Phase 2

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

100Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Hearing Aids, Model P02	Experimental	A body-worn, local made, digital hearing aids Hearing Aids evaluation	Procedure: Hearing Aids Evaluation
Other hearing aids	Active Comparator	Other Hearing Aids, Hearing Aids Evaluation	Procedure: Hearing Aids Evaluation

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Hearing Aids Evaluation	Procedure	Functional Gain Sound field Speech Audiometry	Hearing Aids, Model P02 Other hearing aids

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

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

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

60 Years

Maximum Age

90 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Kwanchanok Yimtae, MD	Khon Kaen University	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Phu Wieng district	Recruiting	Khon Kaen	Changwat Khon Kaen		Thailand

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
34301203	Derived	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.

Type	Date	Date Unknown
Release	Mar 7, 2016
Reset	Apr 5, 2016

ID	Term
D006312	Hearing Loss, Bilateral
D006319	Hearing Loss, Sensorineural

ID	Term
D034381	Hearing Loss
D006311	Hearing Disorders
D004427	Ear Diseases
D010038	Otorhinolaryngologic Diseases