Clinical Study of Minimally Invasive Ponto Surgical Technique (MIPS) - Design Iteration

Oticon Medical

Status: Completed

Conditions: Mixed Hearing Loss; Middle Ear Deafness; Unilateral Deafness; Bone Conduction Deafness

Treatments: Device: Minimally Invasive Ponto Surgery

Study type: Interventional

Funder types: Industry

Identifiers

NCT03807713

C69

Details and patient eligibility

About

The objective of the study is to compare the outcomes after a surgical procedure with minimally invasive Ponto surgery (MIPS, test group) and tissue preservation surgery (control) for placing Oticon Medical Ponto implants and abutments.

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.
• Healthy bone quality to allow for 4mm implant insertion.

Exclusion criteria

• Intraoperative switch to an alternative surgical technique
• Patients undergoing re-implantation (on the side being included in the study)
• Previous participation in the C47 study.
• 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 >12mm (as there will be additional skin reduction needed)

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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25 participants in 1 patient group

Minimally Invasive Ponto Surgery

Other group

Description:

Surgical method for installation of a bone anchored hearing system for hearing rehabilitation

Treatment:

Device: Minimally Invasive Ponto Surgery