RecruitingNot Applicable

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

United States25 participantsStarted 2025-08-15

Plain-language summary

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).

Who can participate

Age range12 Years – 18 Years

SexALL

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Inclusion criteria

✓. Signed Informed Consent Form (signed by parent or legal guardian and child).
✓. Subjects aged 12 to 17 years of age (inclusive)
✓. Subjects with the following audiometric criteria consistent with the current and approved labeling of the device:
✓.1 Conductive or mixed hearing loss with a pure tone average (PTA) bone conduction (BC) threshold (measured at 0.5, 1, 2, and 3 kHz) of the indicated ear better than or equal to 45 dB HL.
✓.2 OR subjects with a profound sensorineural hearing loss in one ear and normal hearing in the opposite ear (i.e., single-sided deafness or "SSD"). The pure tone average air conduction hearing (AC) thresholds of the hearing ear should be better than or equal to 20 dB HL (measured at 0.5, 1, 2, and 3 kHz).
✓.3 OR subjects who are indicated for an air-conduction contralateral routing of signals (AC CROS) hearing aid, but who for some reason cannot or will not use an AC CROS.
✓. Prior experience with amplified sound through properly fitted amplification devices such as a hearing aid, a CROS device, or a non-surgical bone conduction solution (e.g., a softband or sound arc).
✓. For patients with conductive or mixed hearing losses sufficient (e.g., \>25 dB) air bone gap (ABG) at the ear to be implanted.

Exclusion criteria

✕. Medical condition(s) that contraindicates implant surgery or anesthesia.
✕. Untreated ongoing middle ear infection at the time of surgery.
✕. Known or suspected contact allergy to silicone or other material used in the Sentio system.
✕. Insufficient bone quality/quantity/depth or skull size for implantation of a Sentio Ti implant, assessed according to clinical practice.
✕. Known conditions that could jeopardize wound healing and skin condition e.g. uncontrolled diabetes over time or skin or scalp condition(s) that may preclude attachment to, or interfere with usage of, the sound processor as judged by the investigator.
✕. Subject that has received radiotherapy in the area of implantation or is planned for such radiotherapy or similar during the investigation period.
✕. For bilateral asymmetric\* candidates, subjects already treated with a bone-anchored hearing solution on the side with the best BC thresholds.
✕. Known chronic or non-revisable vestibular or balance disorder.

What they're measuring

A. To demonstrate that the Sentio system improves hearing on the implanted ear.

Timeframe: 3months post implantation

Trial details

NCT IDNCT06844071

SponsorOticon Medical

Sponsor typeINDUSTRY

Study typeOBSERVATIONAL

Primary completion2027-04

Contact for this trial

Nicole Amichetti, PhD, MSc

609-366-0424 nitc@oticonmedical.com

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