CompletedNCT01815788TEO FIRSTUpdated Nov 13, 2023

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

An interventional study of Use of a personal sound amplifying device = TeoFirst in Mild and Moderate Presbycusis, sponsored by Centre Hospitalier Universitaire de Nice. Completed at 1 site in France. Open to participants aged 60 Years to 100 Years. Per ClinicalTrials.gov, last updated 2023-11-13.

Sponsored by Centre Hospitalier Universitaire de Nice · Not applicable, Interventional, and Supportive care

Phase: Not applicable
Study type: Interventional
Enrollment: 31
Allocation: Not applicable
Ages: 60 Years to 100 Years
Sex: All

Study 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.

Conditions studied

Mild and Moderate Presbycusis

Browse trials for

Lymphoma, Follicular 964

In context

Lymphoma, Follicular

964 studies on the registry are indexed under Lymphoma, Follicular; 242 are open to participants now.

This study's enrollment of 31 is below the median of 46 across 817 interventional studies indexed under Lymphoma, Follicular.

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Lead sponsor

Centre Hospitalier Universitaire de Nice is the lead sponsor of 722 studies on the registry; 176 are open to participants now.

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Counted across the registry records on this site, refreshed daily.

Who can participate

Ages eligible: 60 Years to 100 Years
Sexes eligible: All
Accepts healthy volunteers: No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

Exclusion Criteria:

Inability to use the device
Previous use of a hearing aid
local intolerance

Study design

Phase: Not applicable
Primary purpose: Supportive care
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrollment: 31 participants (actual)

Study arms

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

Interventions

DeviceUse of a personal sound amplifying device = TeoFirst

What researchers measure

Primary outcomes

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 outcomes

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)
Time frame: D7 to 15 and D 40

Study locations

1 site

CHU de Nice
Nice, 06000, France

References and documents

Publications

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. PubMed 27392722 ↗

Timeline

Tracking since Sep 25, 2026

Not marked actual or estimatedDates not marked actual or estimated

The record gives a start of Apr 2013, a primary completion of Apr 2014 and a completion of Jun 2014. It does not say whether these dates are actual or estimated.

How these figures are worked out, and which studies are left out of them.

Registered: Mar 19, 2013
First posted: Mar 21, 2013
Start: Apr 2013
Primary completionActual: Apr 2014
CompletionActual: Jun 2014
Last update: Nov 13, 2023

What these dates mean

Start.: When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.: When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.: When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.: Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.

No changes since tracking began. The registry record was last updated on Nov 13, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗

Registry details

Key details

Study ID: NCT01815788
Lead sponsor: Centre Hospitalier Universitaire de Nice
Responsible party: Sponsor
First posted: Mar 21, 2013
Start date: Apr 2013
Primary completion: Apr 2014
Completion: Jun 2014
Last update: Nov 13, 2023

Study contacts

Nicolas GUEVARA, PH

principal investigator · Centre Hospitalier Universitaire de Nice

Oversight

Data monitoring committee: No

View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Nov 2023. You cannot join it, but the record below documents what was studied.

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Discussion

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