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

First listed
Feb 25, 2025
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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Atlanta Institute for ENT· Atlanta, GA

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