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The purpose of this study is to in a proactive manner collect high quality data from pediatric patients who have undergone a bone anchored hearing surgery, using the Ponto BHX implant, in clinical practice. This to further increase the knowledge of bone anchored hearing systems in the pediatric population.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treatment | Bone Anchored Hearing Surgery using a BHX implant manufactured by Oticon Medical |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Bone Anchored Hearing Surgery | Device | This is a observational study of pediatric patients undergoing bone anchored hearing surgery. The collected will be used to assess the implant stability development of the Ponto BHX implant during up to 24 months after implantation in a pediatric population undergoing BAHS. The study will also monitor the Ponto BHX implant safety and survival throughout the study period. |
| Measure | Description | Time Frame |
|---|---|---|
| Implant stability | Implant stability will be assessed using resonance frequency analysis (RFA). This is a non-invasive technique using a SmartPeg (no 55) introduced into the abutment top. A probe is directed to the SmartPeg measuring the vibrations as a test for the stability of the interface between the fixture and the bone (osseointegration). The measurement renders Implant Stability Quotient (ISQ) 'numerical values from 1 to 100'; the higher the ISQ value, the higher the stability. Two perpendicular measurements will be performed at each site. The highest and lowest ISQ value obtained at each time point aree recorded. The Osstell ISQ instrument and SmartPegs from Osstell (Gothenburg, Sweden) will be used. Difference in mean of ISQ low at 6 months compared to surgery. | 6 months post surgery |
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Inclusion Criteria:
Exclusion Criteria:
Patients who cannot attend follow up visits.
Patients with single side deafness (SSD).
In surgeon's opinion, any other disorder and condition that may deem the patient unfit to participate in the study.
Patients who receive other implant than the Ponto BHX.
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Pediatric population eligible for a bone anchored hearing surgery
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The James Cook University Hospital | Middlesbrough | TS4 3BE | United Kingdom |
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| ID | Term |
|---|---|
| D006314 | Hearing Loss, Conductive |
| ID | Term |
|---|---|
| D034381 | Hearing Loss |
| D006311 | Hearing Disorders |
| D004427 | Ear Diseases |
| D010038 | Otorhinolaryngologic Diseases |
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|
| D012678 |
| Sensation Disorders |
| D009461 | Neurologic Manifestations |
| D009422 | Nervous System Diseases |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |