Status:
COMPLETED
Multi-Centre Study on the Performance of the Ponto BHX Implant System (in Adult Patients)
Lead Sponsor:
Oticon Medical
Conditions:
Hearing Loss
Eligibility:
All Genders
18+ years
Brief Summary
This multi-centre study funded by Oticon Medical AB will be conducted at seven hospitals across Europe (UK, Spain, Denmark). Patients with a hearing loss and that are already planned for treatment wit...
Detailed Description
This multi-centre study funded by Oticon Medical AB will be conducted at seven hospitals across Europe (UK, Spain, Denmark). Patients with a hearing loss and that are already planned for treatment wit...
Eligibility Criteria
Inclusion
- 18 years of age or older
- Patients indicated for surgical intervention with a bone anchored hearing system according to local clinic's standard guidelines
- Adequate bone quality to allow for a Ponto BHX implant insertion, as judged by the investigator, and an expected bone thickness above 3 mm, where no complications during surgery are expected
Exclusion
- Patients undergoing re-implantation
- Patients who are unable or unwilling to follow investigational procedures/requirements, e.g. to complete quality of life scales.
- Diseases or treatments known to compromise the bone quality at the implant site, e.g. radiotherapy, osteoporosis, diabetes mellitus
- Known conditions (e.g. uncontrolled diabetes) that could jeopardize skin condition and wound healing over time as judged by the investigator
- Any other known condition that the investigator determines could interfere with compliance or study assessments
Key Trial Info
Start Date :
January 17 2021
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
December 20 2023
Estimated Enrollment :
50 Patients enrolled
Trial Details
Trial ID
NCT04310202
Start Date
January 17 2021
End Date
December 20 2023
Last Update
August 29 2024
Active Locations (6)
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1
Aalborg University Hospital
Aalborg, Denmark, 9000
2
Rigshospitalet
Copenhagen, Denmark, 2100
3
Hospital Universitario de Donostia
San Sebastián, Gipuzkoa, Spain, 20014
4
Hospital Clinico Universitario de Valencia
Valencia, Spain, 46010