Back to resultsEvaluation of Efficacy and Patient Acceptance of Sound Amplifier Téo First, in Mild and Moderate Presbycusis Patient 60 Years of Age and Older, With no Previous Hearing Aid (TEO FIRST)
Primary Purpose
- Mild and Moderate Presbycusis (20 to 50 dB Average Hearing Loss at 500, 1000, 2000 Hz and 4000 Hz)
Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Use of a personal sound amplifying device = TeoFirst
Sponsored by
About this trial
This is an interventional supportive care trial for - Mild and Moderate Presbycusis (20 to 50 dB Average Hearing Loss at 500, 1000, 2000 Hz and 4000 Hz)
Eligibility Criteria
Inclusion Criteria:
- Wish to increase hearing
- Moral commitment to use the device
- Ability to understand the study
- Mild and moderate presbycusis (20 to 50 dB average hearing loss at 500, 1000, 2000 Hz and 4000 Hz)
- Patient 60 years of age and older,
- No previous hearing aid
Exclusion Criteria:
- Inability to use the device
- Previous use of a hearing aid
- local intolerance
Sites / Locations
- CHU de Nice
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Teo first
Arm Description
Mild and moderate presbycusis (20 to 50 dB average hearing loss at 500, 1000, 2000 Hz and 4000 Hz) Patient 60 years of age and older, No previous hearing aid
Outcomes
Primary Outcome Measures
Audiometric tests (pure tone and speech) in silence and noise, with and without Teofirst
Secondary Outcome Measures
audiometric and mental tests
Glasgow Hearing Aid Benefit Profile (GHABP)
Acceptability and use questionnaire
ANL (Acceptable Noise Level) test
Mini Mental State Examination
Instrumental Activities of Daily Living (IADL)
Full Information
NCT ID
NCT01815788
First Posted
March 19, 2013
Last Updated
July 28, 2014
Sponsor
Centre Hospitalier Universitaire de Nice
1. Study Identification
Unique Protocol Identification Number
NCT01815788
Brief Title
Evaluation of Efficacy and Patient Acceptance of Sound Amplifier Téo First, in Mild and Moderate Presbycusis Patient 60 Years of Age and Older, With no Previous Hearing Aid
Acronym
TEO FIRST
Official Title
Evaluation of Efficacy and Patient Acceptance of Sound Amplifier Téo First, in Mild and Moderate Presbycusis Patient 60 Years of Age and Older, With no Previous Hearing Aid.
Study Type
Interventional
2. Study Status
Record Verification Date
March 2013
Overall Recruitment Status
Completed
Study Start Date
April 2013 (undefined)
Primary Completion Date
April 2014 (Actual)
Study Completion Date
June 2014 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Centre Hospitalier Universitaire de Nice
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
A personal sound amplifying device (PASP) like Teo First is a wearable electronic product that is not intended to compensate for impaired hearing, but rather is intended for non-hearing impaired consumers to amplify sounds in the environment for a number of reasons, such as for recreational activities. Nevertheless, a lot of mild and moderate impaired hearing people don't want to buy and wear all day a real hearing aid.
The goal of our study is to evaluate the benefit of such a device for mild and moderate presbycusis patient 60 years of age and older, with no previous hearing aid.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
- Mild and Moderate Presbycusis (20 to 50 dB Average Hearing Loss at 500, 1000, 2000 Hz and 4000 Hz)
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
31 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Teo first
Arm Type
Experimental
Arm Description
Mild and moderate presbycusis (20 to 50 dB average hearing loss at 500, 1000, 2000 Hz and 4000 Hz)
Patient 60 years of age and older,
No previous hearing aid
Intervention Type
Device
Intervention Name(s)
Use of a personal sound amplifying device = TeoFirst
Primary Outcome Measure Information:
Title
Audiometric tests (pure tone and speech) in silence and noise, with and without Teofirst
Time Frame
7 to 15 days after the first use of Teofirst
Secondary Outcome Measure Information:
Title
audiometric and mental tests
Description
Glasgow Hearing Aid Benefit Profile (GHABP)
Acceptability and use questionnaire
ANL (Acceptable Noise Level) test
Mini Mental State Examination
Instrumental Activities of Daily Living (IADL)
Time Frame
D7 to 15 and D 40
10. Eligibility
Sex
All
Minimum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Wish to increase hearing
Moral commitment to use the device
Ability to understand the study
Mild and moderate presbycusis (20 to 50 dB average hearing loss at 500, 1000, 2000 Hz and 4000 Hz)
Patient 60 years of age and older,
No previous hearing aid
Exclusion Criteria:
Inability to use the device
Previous use of a hearing aid
local intolerance
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Nicolas GUEVARA, PH
Organizational Affiliation
Centre Hospitalier Universitaire de Nice
Official's Role
Principal Investigator
Facility Information:
Facility Name
CHU de Nice
City
Nice
ZIP/Postal Code
06000
Country
France
12. IPD Sharing Statement
Citations:
PubMed Identifier
27392722
Citation
Sacco G, Gonfrier S, Teboul B, Gahide I, Prate F, Demory-Zory M, Turpin JM, Vuagnoux C, Genovese P, Schneider S, Guerin O, Guevara N. Clinical evaluation of an over-the-counter hearing aid (TEO First(R)) in elderly patients suffering of mild to moderate hearing loss. BMC Geriatr. 2016 Jul 9;16:136. doi: 10.1186/s12877-016-0304-4.
Results Reference
derived
Learn more about this trial
Evaluation of Efficacy and Patient Acceptance of Sound Amplifier Téo First, in Mild and Moderate Presbycusis Patient 60 Years of Age and Older, With no Previous Hearing Aid
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