Actively Recruiting
The Sentio System: Post-market Evaluation of Safety and Performance in Adolescents
Led by Oticon Medical · Updated on 2025-09-22
25
Participants Needed
1
Research Sites
102 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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).
CONDITIONS
Official Title
The Sentio System: Post-market Evaluation of Safety and Performance in Adolescents
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Signed informed consent form by parent or legal guardian and child
- Age between 12 and 17 years inclusive
- Conductive or mixed hearing loss with bone conduction threshold of the ear to be implanted better than or equal to 45 dB HL
- OR profound sensorineural hearing loss in one ear with normal hearing in the opposite ear (single-sided deafness) with air conduction hearing thresholds better than or equal to 20 dB HL
- OR indicated for an air-conduction contralateral routing of signals (AC CROS) hearing aid but unable or unwilling to use it
- Prior experience with amplified sound through hearing aids, CROS devices, or non-surgical bone conduction solutions
- Sufficient air bone gap (greater than 25 dB) at the ear to be implanted
- Ability and willingness of subject and parent/legal guardian to comply with investigational procedures
You will not qualify if you...
- Medical condition contraindicating implant surgery or anesthesia
- Untreated ongoing middle ear infection at time of surgery
- Known or suspected allergy to silicone or other materials in the Sentio system
- Insufficient bone quality, quantity, or skull size for implantation
- Conditions that could affect wound healing or skin condition, such as uncontrolled diabetes or skin/scalp conditions affecting device use
- Previous or planned radiotherapy in the implantation area during the study
- Prior treatment with bone-anchored hearing solution on the side with best bone conduction thresholds for bilateral asymmetric candidates
- Known chronic or irreversible vestibular or balance disorders
- Abnormally progressive sensorineural hearing loss
- Participation in another clinical trial involving investigational drug/device within 30 days
- Use of active implantable or body-worn devices that cannot be removed
- Need for frequent MRI scans for other diseases
- Current or planned use of ototoxic drugs harmful to hearing
- Known retro cochlear pathology or auditory processing disorders impacting study outcome
- Any developmental, learning delay, or condition interfering with compliance or assessments
- Deemed unsuitable for enrollment according to Declaration of Helsinki
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Atlanta Institute for ENT
Atlanta, Georgia, United States, 30342
Actively Recruiting
Research Team
N
Nicole Amichetti, PhD, MSc
CONTACT
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
1
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