TEO FIRST: 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

• Sponsor: Centre Hospitalier Universitaire de Nice (Other)
• Overall Status: Completed
• CT.gov ID: NCT01815788
• Collaborator: (none)
• Enrollment: 31
• Location: 1
• Arm: 1
• Duration (Months): 14
• Patients Per Site Per Month: 2.2

Study Details

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.

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	N/A

Study Design

• Study Type: Interventional
• 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: Apr 1, 2013
• Actual Primary Completion Date: Apr 1, 2014
• Actual Study Completion Date: Jun 1, 2014

Arms and Interventions

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

Primary Outcome Measures

1. Audiometric tests (pure tone and speech) in silence and noise, with and without Teofirst [7 to 15 days after the first use of Teofirst]

Secondary Outcome Measures

1. audiometric and mental tests [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

Criteria

• Ages Eligible for Study: 60 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Locations

	Site	City	State	Country	Postal Code
1	CHU de Nice	Nice		France	06000

Sponsors and Collaborators

• Centre Hospitalier Universitaire de Nice

Investigators

• Principal Investigator: Nicolas GUEVARA, PH, Centre Hospitalier Universitaire de Nice

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Centre Hospitalier Universitaire de Nice
• ClinicalTrials.gov Identifier: NCT01815788
• Other Study ID Numbers: 12-PP-17
• First Posted: Mar 21, 2013
• Last Update Posted: Jul 29, 2014
• Last Verified: Mar 1, 2013

• Additional relevant MeSH terms: Hearing Loss; Presbycusis

Study Results

No Results Posted as of Jul 29, 2014