Hearing Aid, Hearing-Impairment, Hearing Loss, Hearing Loss, Bilateral or Unilateral, Hearing Loss, Conductive, Hearing Loss, Mixed Conductive-Sensorineural, Single Sided Deafness
Conditions
Keywords
Active transcutaneous bone conduction hearing system
Brief 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.
Interventions
DEVICETranscutaneous bone conduction hearing system
The Sentio system is an active transcutaneous bone conduction hearing system (single armed study)
Sponsors
Oticon Medical
Study design
Observational model
COHORT
Time perspective
OTHER
Eligibility
Sex/Gender
ALL
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Rate of succesful use of the device | 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. | 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). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Frequency of surgical events and complications | During surgery | — |
| Assess surgical approaches and techniques | During surgery | — |
| Frequency of post-operative complications | From surgery till end of follow-up (expected up to 10 years) | — |
| Timing of fitting | During fitting appointment (typically 2-15 weeks after surgery, depending on patient needs and local variations on practice) | Days between surgery and fitting of sound processor. |
| To assess improvement in hearing | At fitting and throughout follow-up period (expected up to 10 years) | Free-field thresholds |
Contacts
Primary ContactKia N Iversen, PhD
Outcome results
None listed