ClinicalTrials.gg
Not yet recruitingNCT07161154SENSEUpdated Sep 8, 2025

Sentio Systematic Evaluation

An observational study in Hearing Loss, Bilateral or Unilateral, Hearing Loss, Conductive and Hearing Loss, Mixed Conductive-Sensorineural, sponsored by Oticon Medical. Not yet recruiting. Per ClinicalTrials.gov, last updated 2025-09-08.

Sponsored by Oticon Medical · Observational

Study type
Observational
Model
Cohort
Time perspective
Other
Enrollment
100
Sex
All
01

Study summary

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.

02

Conditions studied

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

Keywords

  • Active transcutaneous bone conduction hearing system
03

In context

Hearing Loss

796 studies on the registry are indexed under Hearing Loss; 193 are open to participants now.

This study's planned enrollment of 100 is close to the median of 100 across 192 observational studies indexed under Hearing Loss.

Browse Hearing Loss studies →

Lead sponsor

Oticon Medical is the lead sponsor of 45 studies on the registry; 6 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
Child (0–17), Adult (18–64), Older adult (65+)
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

Patients receiving the Sentio system in clinical practice

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Subject who is scheduled for or have undergone Sentio implantation in clinical practice.
  • Subject who has consented to participation or are covered by consent waiver.

Exclusion criteria

Exclusion Criteria:

  • Subjects enrolled in other clinical investigations leading to their Sentio implantation and subsequent follow-up deviating substantially from clinical practice
05

Study design

Observational model
Cohort
Time perspective
Other
Enrollment
100 participants (estimated)
Patient registry
No

Groups and cohorts

  • Sentio

    Patients recieving the Sentio system

    Device: Transcutaneous bone conduction hearing system

Interventions

  • DeviceTranscutaneous bone conduction hearing system

    The Sentio system is an active transcutaneous bone conduction hearing system (single armed study)

06

What researchers measure

Primary outcomes

  1. Rate of succesful use of the device

    Successful use is defined as a composite outcome consisting of completion of the surgical procedure and patient reported satisfaction after fitting and use of the device (assessed through a device specific questionnaire).

    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.

Secondary outcomes

  1. Frequency of surgical events and complications

    Time frame: During surgery

  2. Assess surgical approaches and techniques

    Time frame: During surgery

  3. Frequency of post-operative complications

    Time frame: From surgery till end of follow-up (expected up to 10 years)

  4. Timing of fitting

    Days between surgery and fitting of sound processor.

    Time frame: During fitting appointment (typically 2-15 weeks after surgery, depending on patient needs and local variations on practice)

  5. To assess improvement in hearing

    Free-field thresholds

    Time frame: At fitting and throughout follow-up period (expected up to 10 years)

07

Study locations

No study locations are listed for this record.

08

References and documents

Individual participant data

Plan to share: No — To protect integrity of patients.

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Sep 8, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT07161154
Lead sponsor
Oticon Medical
Responsible party
Sponsor
First posted
Sep 8, 2025
Start date
Sep 2025 (estimated)
Primary completion
Dec 2035 (estimated)
Completion
Dec 2035 (estimated)
Last update
Sep 8, 2025

Study contacts

Kia N Iversen, PhD
Contact
kinv@oticonmedical.com
+46760039141

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Sep 2025. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion