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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 (TEO FIRST)

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ClinicalTrials.gov Identifier: NCT01815788
Recruitment Status : Completed
First Posted : March 21, 2013
Last Update Posted : July 29, 2014
Sponsor:
Information provided by (Responsible Party):
Centre Hospitalier Universitaire de Nice

Study Description
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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.


Condition or disease Intervention/treatment Phase
- Mild and Moderate Presbycusis (20 to 50 dB Average Hearing Loss at 500, 1000, 2000 Hz and 4000 Hz) Device: Use of a personal sound amplifying device = TeoFirst Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 31 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
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 Start Date : April 2013
Actual Primary Completion Date : April 2014
Actual Study Completion Date : June 2014

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: Teo first
  • 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
 Device: Use of a personal sound amplifying device = TeoFirst


Outcome Measures
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Primary Outcome Measures :
  1. 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 Measures :
  1. audiometric and mental tests [ Time Frame: D7 to 15 and D 40 ]
    • 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)


Eligibility Criteria
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Ages Eligible for Study:   60 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01815788


Locations
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France
CHU de Nice
Nice, France, 06000
Sponsors and Collaborators
Centre Hospitalier Universitaire de Nice
Investigators
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Principal Investigator: Nicolas GUEVARA, PH Centre Hospitalier Universitaire de Nice
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Centre Hospitalier Universitaire de Nice
ClinicalTrials.gov Identifier: NCT01815788    
Other Study ID Numbers: 12-PP-17
First Posted: March 21, 2013    Key Record Dates
Last Update Posted: July 29, 2014
Last Verified: March 2013
Additional relevant MeSH terms:
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Hearing Loss
Presbycusis
Hearing Disorders
Ear Diseases
Otorhinolaryngologic Diseases
 Sensation Disorders
Neurologic Manifestations
Nervous System Diseases
Hearing Loss, Sensorineural