Clinical Survey of Oticon Medical Ponto Implants and a Surgical Technique With Tissue Preservation

Oticon Medical

Status: Completed

Conditions: Mixed Hearing Loss; Single Sided Deafness; Conductive Hearing Loss

Study type: Observational

Funder types: Other; Industry

Identifiers

NCT02064478

C47

Details and patient eligibility

About

A bone anchored hearing system is used to improve hearing for patients with e.g. conductive/mixed hearing loss or single sided deafness.

With this type of system, a titanium implant is installed in the temporal bone, where it osseointegrates, i.e. integrates with the bone. An abutment (also in titanium) is attached to the implants and penetrates the skin. The sound processor (hearing aid) is then connected to the abutment, and can be attached and removed by the patient via a snap-coupling. This type of system has been successfully implanted in more than 100.000 patients. Recently, a simplified surgical procedure, where no skin thinning around the abutment is made, was approved. The results after using this installation technique, here called soft tissue preservation, are the focus of this study.

The objective of the study is to compare the outcomes after a surgical procedure with soft tissue preservation (test) and a surgery with soft tissue reduction (control) for placing Oticon Medical Ponto implants and abutments. The main hypothesis is that patient numbness around the implant is less in the test group compared to the control group.

Enrollment: 25 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

• 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.
• Patients with natural skin height of >10 mm

Trial design

25 participants in 2 patient groups

Tissue preservation

Description:

Ponto implant installed using a tissue preservation surgical technique

Tissue reduction

Description:

Ponto implant installed using a classical technique with skin thinning