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)

This study is not yet open for participant recruitment.
Verified March 2013 by Centre Hospitalier Universitaire de Nice
Sponsor:
Information provided by (Responsible Party):
Centre Hospitalier Universitaire de Nice
ClinicalTrials.gov Identifier:
NCT01815788
First received: March 19, 2013
Last updated: March 20, 2013
Last verified: March 2013
  Purpose

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 Intervention
- 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

Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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.

Resource links provided by NLM:


Further study details as provided by Centre Hospitalier Universitaire de Nice:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • audiometric and mental tests [ Time Frame: D7 to 15 and D 40 ] [ Designated as safety issue: No ]
    • 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)


Estimated Enrollment: 35
Study Start Date: April 2013
Estimated Study Completion Date: June 2014
Estimated Primary Completion Date: April 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   60 Years and older
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01815788

Contacts
Contact: Vanina OLIVERI, CRA 04 92 03 42 54 oliveri.v@chu-nice.fr
Contact: Vanessa ESPIN, CRA stagiaire 04 92 03 42 54 espin.v@chu-nice.fr

Locations
France
CHU de Nice Not yet recruiting
Nice, France, 06000
Contact: Nicolas GUEVARA, PH       guevara.n@chu-nice.fr   
Principal Investigator: Nicolas GUEVARA, PH         
Sub-Investigator: Yvan GAHIDE, PH         
Sub-Investigator: Olivier GUERIN, PU-PH         
Sub-Investigator: Guillaume SACCO, PH         
Sub-Investigator: Jean Michel TURPIN, PH         
Sponsors and Collaborators
Centre Hospitalier Universitaire de Nice
Investigators
Principal Investigator: Nicolas GUEVARA, PH CHU de Nice
  More Information

No publications provided

Responsible Party: Centre Hospitalier Universitaire de Nice
ClinicalTrials.gov Identifier: NCT01815788     History of Changes
Other Study ID Numbers: 12-PP-17
Study First Received: March 19, 2013
Last Updated: March 20, 2013
Health Authority: France: Committee for the Protection of Personnes
France: Agence Nationale de Sécurité du Médicament et des produits de santé

Additional relevant MeSH terms:
Hearing Loss
Deafness
Presbycusis
Hearing Disorders
Ear Diseases
Otorhinolaryngologic Diseases
Sensation Disorders
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Hearing Loss, Sensorineural

ClinicalTrials.gov processed this record on April 15, 2014