The Sentio System: Post-market Evaluation of Safety and Performance in Adolescents

Part of paid clinical trials in Atlanta, Georgia.

Sponsor
Oticon Medical
Study ID
NCT06844071
Status
Recruiting
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Conditions

  • Hearing Loss

Eligibility Criteria

Sex
ALL
Age
12 Years - 18 Years
Healthy Volunteers
Not accepted

Study Details

This study is a post-market, multicentre, prospective, single arm investigation aimed to systematically collect safety and performance data on the Sentio system, when used as intended for adolescents (12-17 years inclusive).

Key Dates

Start date
Aug 15, 2025
Status verified
Sep 2025
Primary completion
Apr 30, 2027
Completion
Aug 31, 2027

Study Design

Enrollment
25 participants (estimated)

Arms

  • Arm: subjects

Primary Outcome Measure

A. To demonstrate that the Sentio system improves hearing on the implanted ear. [ Time Frame: 3months post implantation ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Atlanta Institute for ENTAtlantaGeorgia30342
Jolie Fainberg, AuD

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By research site
Atlanta Institute for ENT· Atlanta, GA

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