Long-term Stability and Survival Rates of a Novel Oticon Medical Bone Conduction Device Implant

Oticon Medical

Status: Completed

Conditions: Hearing Loss, Conductive; Hearing Disorders; Otorhinolaryngologic Diseases; Ear Diseases; Hearing Loss; Deafness

Treatments: Device: Bone anchored hearing implant

Study type: Interventional

Funder types: Industry

Identifiers

NCT01738490

C33

Details and patient eligibility

About

The overall aim of the study is to investigate the Ponto wide implant considering; initial implant stability, stability over time, skin reaction and long term success when loaded at 3 weeks post surgery. Patients' quality of life improvements following implantation will also be surveyed.

More specifically the primary objective of this clinical study is to test the hypothesis

• The new Ponto wide diameter implant offers increased implant stability measured as ISQ (implant stability quotient) compared to the previous generation Ponto implant.

And the secondary objective is to

• Investigate when in time implant stability is the lowest as the initial mechanical stability is gradually replaced by biological stability

Enrollment: 59 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 18 years or older
• Patient indicated for an ear level bone anchored sound processor
• Bone thickness at the implant site of at least 4 mm

Exclusion criteria

• Longer abutment (>6mm) required
• Inability to participate in follow-up
• Psychiatric disease in the medical history
• Mental disability
• Presumed doubt, for any reason, that the patient will be able to show up on all follow ups
• Diseases or treatments known to compromise the bone quality at the implant site, e.g. radiotherapy, osteoporosis, diabetes mellitus.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

59 participants in 2 patient groups

Wide diameter implant

Other group

Description:

Bone anchored hearing implant For the wide diameter arm (test group), the Ponto wide implant (diameter 4,5mm, length 4mm) and abutment 6mm developed by Oticon Medical AB (Gothenburg, Sweden) will be installed.

Treatment:

Device: Bone anchored hearing implant

Control group

Other group

Description:

Bone anchored hearing implant For the control group, the previous generation Ponto implant (diameter 3,75mm, length 4mm) and 6mm abutment (Oticon Medical AB, Gothenburg, Sweden) will be installed.

Treatment:

Device: Bone anchored hearing implant