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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Sentio | Patients recieving the Sentio system |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Transcutaneous bone conduction hearing system | Device | The Sentio system is an active transcutaneous bone conduction hearing system (single armed study) |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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). | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Frequency of surgical events and complications | During surgery | |
| Assess surgical approaches and techniques | During surgery | |
| Frequency of post-operative complications |
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Inclusion Criteria:
Exclusion Criteria:
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Patients receiving the Sentio system in clinical practice
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Kia N Iversen, PhD | Contact | +46760039141 | kinv@oticonmedical.com |
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To protect integrity of patients.
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| ID | Term |
|---|---|
| D034381 | Hearing Loss |
| D006314 | Hearing Loss, Conductive |
| D046089 | Hearing Loss, Mixed Conductive-Sensorineural |
| ID | Term |
|---|---|
| D006311 | Hearing Disorders |
| D004427 | Ear Diseases |
| D010038 | Otorhinolaryngologic Diseases |
| D012678 | Sensation Disorders |
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| From surgery till end of follow-up (expected up to 10 years) |
| Timing of fitting | Days between surgery and fitting of sound processor. | During fitting appointment (typically 2-15 weeks after surgery, depending on patient needs and local variations on practice) |
| To assess improvement in hearing | Free-field thresholds | At fitting and throughout follow-up period (expected up to 10 years) |
| D009461 |
| Neurologic Manifestations |
| D009422 | Nervous System Diseases |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |