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

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.

Study Overview

• Status: Completed
• Conditions: Conductive Hearing Loss; Single Sided Deafness; Mixed Hearing Loss

• Study Type: Observational
• Enrollment (Actual): 25

Contacts and Locations

Study Locations

• Netherlands
  • Nijmegen, Netherlands, 6500 HB
    • Radboud University Medical Centre

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

All patients to be included are already planned for treatment with a bone anchored hearing aid at Radboud University Nijmegen Medical Centre (Nijmegen, The Netherlands).

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort
Tissue preservation; Ponto implant installed using a tissue preservation surgical technique
Tissue reduction; Ponto implant installed using a classical technique with skin thinning

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Numbness around implant, specifically mean Total sensibility	36 months after surgery

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Length of surgery		At surgery
Sum of number of unplanned visits, revision surgeries, medications related to implant, and other treatments requiring medical staff per patient		0-6 months
Mild/Adverse skin reaction	Adverse skin reaction is defined as a Holgers score ≥ 2 at least one follow-up visit, including unplanned visits, during the analysis period Holgers score is a standardized score of skin reactions around a bone anchored hearing implant.	0-6 months
Skin condition according to Holgers	Holgers score is a standardized score of skin reactions around a bone anchored hearing implant.	7 days after surgery
Postoperative complications	Including; Bleeding or hematoma; Flap necrosis; Wound dehiscence; Other (description)	7 days to 6 months
Proportion of patients with complete wound healing at first surgical visit		7 days
Glasgow Benefit Inventory (GBI) scores		3 months
Glasgow Health Status Inventory (GHSI) scores		Baseline (before surgery)
Abbreviated profile of hearing aid benefit (APHAB) scores		Baseline (before surgery)
Mean hours of use of the sound processor		0-6 months
Sum of number of unplanned visits, revision surgeries, medications related to implant, and other treatments requiring medical staff per patient		0-12 months
Sum of number of unplanned visits, revision surgeries, medications related to implant, and other treatments requiring medical staff per patient		0-36 months
Bone conduction (BC) in-situ audiometric thresholds		6 months
Bone conduction (BC) audiometric threshold	Measured with B-71	6 months
Mean total sensibility around implant		Baseline (before surgery)
Implant stability quotient (ISQ)		At surgery
Time to implant loss		0-36 months
Patient and Observer scar assessment score		21 days post surgery
Mild/Adverse skin reaction	Adverse skin reaction is defined as a Holgers score ≥ 2 at least one follow-up visit, including unplanned visits, during the analysis period	0-12 months
Mild/Adverse skin reaction	Adverse skin reaction is defined as a Holgers score ≥ 2 at least one follow-up visit, including unplanned visits, during the analysis period	0-36 months
Skin condition according to Holgers		21 days
Skin condition according to Holgers		12 weeks
Skin condition according to Holgers		6 months
Skin condition according to Holgers		1 year
Skin condition according to Holgers		2 years
Skin condition according to Holgers		3 years after surgery
Postoperative complications	Including; Bleeding or hematoma; Flap necrosis; Wound dehiscence; Other (description)	7 days to 12 months
Postoperative complications	Including; Bleeding or hematoma; Flap necrosis; Wound dehiscence; Other (description)	7 days to 36 months
Glasgow Benefit Inventory (GBI) scores		12 months
Glasgow Health Status Inventory (GHSI) scores		6 months
Glasgow Health Status Inventory (GHSI) scores		36 months
Abbreviated profile of hearing aid benefit (APHAB) scores		6 months
Abbreviated profile of hearing aid benefit (APHAB) scores		36 months
Mean hours of use of the sound processor		0-36 months
Mean total sensibility around implant		21 days
Mean total sensibility around implant		6 months
Mean total sensibility around implant		12 months
Mean total sensibility around implant		36 months
Implant stability quotient (ISQ)		7 days post surgery
Implant stability quotient (ISQ)		21 days post surgery
Implant stability quotient (ISQ)		12 weeks post surgery
Implant stability quotient (ISQ)		6 months post surgery
Implant stability quotient (ISQ)		12 months post surgery
Implant stability quotient (ISQ)		24 months post surgery
Implant stability quotient (ISQ)		36 months post surgery
Patient and Observer scar assessment score		6 months
Patient and Observer scar assessment score		12 months
Patient and Observer scar assessment score		36 months

Other Outcome Measures

Outcome Measure	Time Frame
Skin height around abutment (in mm)	At surgery
Skin height around abutment (in mm)	7 days post surgery
Skin height around abutment (in mm)	21 days post surgery
Skin height around abutment (in mm)	12 weeks post surgery
Skin height around abutment (in mm)	6 months post surgery
Skin height around abutment (in mm)	12 months post surgery
Skin height around abutment (in mm)	36 months post surgery

Collaborators and Investigators

• Sponsor: Oticon Medical
• Collaborators: Statistiska Konsultgruppen
• Investigators: Principal Investigator: Myrthe KS Hol, MD, PhD, Radboud University Medical Center; Principal Investigator: Emmanuel AM Mylanus, MD, PhD, Radboud University Medical Center

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (ACTUAL): February 1, 2014
• Primary Completion (ACTUAL): April 1, 2015
• Study Completion (ACTUAL): September 1, 2017

Study Registration Dates

• First Submitted: February 14, 2014
• First Submitted That Met QC Criteria: February 14, 2014
• First Posted (ESTIMATE): February 17, 2014

Study Record Updates

• Last Update Posted (ACTUAL): February 22, 2018
• Last Update Submitted That Met QC Criteria: February 20, 2018
• Last Verified: February 1, 2018

More Information

Terms related to this study

• Keywords: Bone anchored hearing implant; Bone anchored hearing device
• Additional Relevant MeSH Terms: Nervous System Diseases; Neurologic Manifestations; Otorhinolaryngologic Diseases; Ear Diseases; Sensation Disorders; Hearing Disorders; Hearing Loss; Deafness; Hearing Loss, Conductive; Hearing Loss, Mixed Conductive-Sensorineural
• Other Study ID Numbers: C47

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO