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Conductive Hearing Loss | Clinical Survey of Oticon Medical Ponto Implants and a Surgical Technique With Tissue Preservation

Conductive Hearing Loss research study

What is the primary objective of this study?

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.

Who is eligible to participate?

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

Which medical condition, disease, disorder, syndrome, illness, or injury is researched?

Conductive Hearing Loss

Mixed Hearing Loss

Single Sided Deafness

Study Interventions

Interventions can include giving participants drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available or noninvasive approaches such as surveys, education, and interviews.

Study Arms

Research studies and clinical trials typically have two or more research arms. An arm is a group of people who receive the same treatment in the study.

Tissue preservationPonto implant installed using a tissue preservation surgical technique

Tissue reductionPonto implant installed using a classical technique with skin thinning

Study Status

Active, not recruiting

Start Date: February 2014

Completed Date: October 2017

Phase: N/A

Type: Observational

Design:

Primary Outcome: Numbness around implant, specifically mean Total sensibility

Secondary Outcome: Length of surgery

Study sponsors, principal investigator, and references

Principal Investigator: Myrthe KS Hol, MD, PhD

Lead Sponsor: Oticon Medical

Collaborator: Statistiska konsultgruppen

More information:https://clinicaltrials.gov/show/NCT02064478

den Besten CA, Bosman AJ, Nelissen RC, Mylanus EA, Hol MK. Controlled Clinical Trial on Bone-anchored Hearing Implants and a Surgical Technique With Soft-tissue Preservation. Otol Neurotol. 2016 Jun;37(5):504-12. doi: 10.1097/MAO.0000000000000994.

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