Minimally Invasive Surgery for Ponto Bone Anchored Hearing Implants (C50)

Oticon Medical

Status: Completed

Conditions: Mixed Conductive-sensorineural Hearing Loss; Unilateral Partial Deafness; Conductive Hearing Loss

Treatments: Procedure: Surgery for Ponto bone anchored hearing aids

Study type: Interventional

Funder types: Industry

Identifiers

NCT02438618

C50

Details and patient eligibility

About

The objective of this study is to make a comparison between two surgical techniques used when implanting a Ponto bone anchored hearing system.

Enrollment: 64 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Adult patient, i.e. ≥ 18 years of age
• Eligible for the Ponto system

Exclusion criteria

• Known history of immunosuppressive disease
• Use of systemic immunosuppressive medication
• Receiving bilateral bone anchored hearing system
• Relevant dermatological diseases as judged by the investigator
• Not being able to finish the study, for example because of failure to complete the questionnaires
• Participating in another study with medical aids or medication
• When there is no suitable implantation-site for the 4 mm implant during surgery because of insufficient bone quality.

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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64 participants in 2 patient groups

Minimally invasive punch technique

Experimental group

Description:

New surgical technique for Ponto bone anchored hearing implants

Treatment:

Procedure: Surgery for Ponto bone anchored hearing aids

Hultcrantz technique

Other group

Description:

Standard surgical technique for bone anchored hearing implants

Treatment:

Procedure: Surgery for Ponto bone anchored hearing aids