Sentio Systematic Evaluation (SENSE)

Oticon Medical

Status: Not yet enrolling

Conditions: Hearing Loss, Conductive; Hearing-Impairment; Hearing Loss, Mixed Conductive-Sensorineural; Hearing Loss, Bilateral or Unilateral; Hearing Loss; Hearing Aid; Single Sided Deafness

Treatments: Device: Transcutaneous bone conduction hearing system

Study type: Observational

Funder types: Industry

Identifiers

NCT07161154

BC125

Details and patient eligibility

About

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.

Enrollment: 100 estimated patients

Sex: All

Volunteers: No Healthy Volunteers

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

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

Trial design

100 participants in 1 patient group

Sentio

Description:

Patients recieving the Sentio system

Treatment:

Device: Transcutaneous bone conduction hearing system