Sentio Systematic Evaluation

Sponsor
Oticon Medical
Study ID
NCT07161154
Status
Not Yet Recruiting

Notify me when recruiting opens

Save your spot on the interest list for this study. We'll keep your details with this study so our team can follow up when recruiting opens.

Not yet recruiting

Add your contact details and location so we can keep your interest tied to this study.

Conditions

  • Hearing Aid
  • Hearing Loss
  • Hearing Loss, Bilateral or Unilateral
  • Hearing Loss, Conductive
  • Hearing Loss, Mixed Conductive-Sensorineural
  • Hearing-Impairment
  • Single Sided Deafness

Eligibility Criteria

Sex
ALL
Age
N/A - N/A
Healthy Volunteers
Not accepted

Interventions

  • Transcutaneous bone conduction hearing system — DEVICE
    The Sentio system is an active transcutaneous bone conduction hearing system (single armed study)

Study Details

The study is designed as an international, multi-center, single-armed, non-interventional/observational study including subjects who has received or are planned to receive the Sentio system as part of normal clinical practice.

Key Dates

First listed
Sep 8, 2025
Start date
Sep 30, 2025
Status verified
Sep 2025
Primary completion
Dec 31, 2035
Completion
Dec 31, 2035

Study Design

Enrollment
100 participants (estimated)

Arms

  • Arm: Sentio
    Patients recieving the Sentio system

Primary Outcome Measure

Rate of succesful use of the device [ Time Frame: Completion of the surgical procedure is reported at the surgery. Device specific questionnaire is typically completed within the first year of follow-up, though timing may vary depending on local practice for follow-up. ]

Central Contacts

Related Studies