10-year Follow-up of the Ponto Wide-implant

Long Term Follow-up of the Ponto Wide Implant: 10 Years of Clinical Evaluation

The goal of this single center, prospective study is to investigate the survival of the Ponto Wide Implant at least 10 years after implantation.

Secondary objectives are:

1. To determine the amount and causes of implant loss and implant and/or abutment removal.
2. To establish the stability of the implant.
3. To assess skin complications.
4. To investigate daily usage and the number of hours of use of the sound processor.
5. To determine the quality of life.

During a check-up of the implant at the outpatient clinic, the skin around the implant will be assessed, the stability of the implant will be measured, and the patient will be asked to complete two questionnaires.

Study Overview

• Status: Enrolling by invitation
• Conditions: Survival of the Ponto Wide Implant

Detailed Description

Patients who participated in the previous studies concerning the Ponto Wide implant from Oticon (3 years after implantation) will be approached. If consent is given, they will be added to the database of the already completed studies, and new data will be stored in the same database. The patients were already pseudonymized in the previous studies, and the database is secured with a code that is only accessible to individuals directly involved in the research

• Study Type: Observational
• Enrollment (Estimated): 64

Contacts and Locations

Study Locations

• Netherlands
  • Gelderland
    • Nijmegen, Gelderland, Netherlands, 6525 GA
      • Radboudumc

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

The study population consists of patients who received a Ponto Wide implant (4.5 mm diameter, 4.0 mm length) at least 10 years ago and previously participated in one of two already completed studies.

Description

Inclusion Criteria:

• Implantation with Ponto Wide implant (diameter 4.5 mm, length 4.0 mm)
• Ten or more years of post-operative follow-up.
• Valid informed consent

Exclusion Criteria:

• No specific exclusion criteria have been set for the study.

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort

Patients with a Ponto Wide Implant for 10 years; The study population consists of patients who received a Ponto Wide implant (4.5 mm diameter, 4.0 mm length) at least 10 years ago. Only patients who participated in one of the two previous completed studies (Long-term stability and survival rates of a novel Oticon Medical bone conduction device implant, Three-year Outcomes of a Randomized Controlled Trial Comparing a 4.5-mm-Wide to a 3.75-mm-Wide Titanium Implant for Bone Conduction Hearing) will be included

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Implant survival	The number of Ponto Wide implants that have survived 10 years after implantation.	It will be assessed during the clinic visit between November 2024 and March 2025.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Amount of implant loss	The number of implant losses over the past 10 years based on the patient files.	This will be examined during the period from November 2024 to March 2025
Reasons of implant loss	The reason for each implant loss.	This will be examined during the period from November 2024 to March 2025
Amount of abutment loss	The number of abutment losses over the past 10 years based on the patient files.	This will be examined during the period from November 2024 to March 2025
Reasons of abutment loss	The reason for each abutment loss.	This will be examined during the period from November 2024 to March 2025
Amount of implant removal	The number of implant removal over the past 10 years based on the patient files.	This will be examined during the period from November 2024 to March 2025
Reasons of implant removal	The reason for each implant removal.	This will be examined during the period from November 2024 to March 2025
Amount of abutment removal	The number of abutment removals over the past 10 years based on the patient files.	This will be examined during the period from November 2024 to March 2025
Reasons of abutment removal	The reason for each abutment removal.	This will be examined during the period from November 2024 to March 2025
Implant stability Quotient (ISQ) measured using Osstell	ISQ (implant Stability Quotient) is a measurement scale for use with the Resonance Frequency Analysis (RFA) method of determining implant stability. The measurement is made using the Osstell Mentor equipment (Osstell, Sweden) with SmartPegs. ISQ values range from 1 to 100, the higher the score the higher the stability. The highest and lowest score obtained from perpendicular measurements will be registered.	It will be assessed during the clinic visit between November 2024 and March 2025.
Skin complication	Skin complication rates at >10-year follow-up are assessed using both the Holgers classification and the IPS-score. Both classification systems are standardized scales to clinically assess the skin condition around the implant.	It will be assessed during the clinic visit between November 2024 and March 2025.
Sound processor use	Average sound processor usage (hours per day; days/week) >10 years post-surgery.	It will be assessed during the clinic visit between November 2024 and March 2025.
Glasgow Benefit Inventory (GBI)	The GBI questionnaire is used to evaluate the quality of life after a medical intervention. The questionnaire consists of 18 items corresponding to different aspects of the patient's well-being: quality of life, self-confidence, support, general health, and social involvement. The scoring ranges from 1 to 5, indicating that a higher score means the statement is more applicable to the patient after the intervention.	It will be assessed during the clinic visit between November 2024 and March 2025.
International Outcome Inventory for Hearing Aids (IOI-HA)	The IOI-HA questionnaire is a seven-item tool designed to be broadly applicable in evaluating the effectiveness of hearing aid treatments. These questions provide insight into how satisfied patients are with their hearing aids. Each statement offers five possible responses on an ascending scale, indicating whether the answer is more or less applicable to the statement.	It will be assessed during the clinic visit between November 2024 and March 2025.

Collaborators and Investigators

• Sponsor: University Medical Center Nijmegen
• Collaborators: Oticon Medical
• Investigators: Principal Investigator: Emmanuel Myalnus, Prof. dr., Radboud University Medical Center

Publications and helpful links

General Publications

• Kruyt IJ, Kok H, Bosman A, Nelissen RC, Mylanus EAM, Hol MKS. Three-Year Clinical and Audiological Outcomes of Percutaneous Implants for Bone Conduction Devices: Comparison Between Tissue Preservation Technique and Tissue Reduction Technique. Otol Neurotol. 2019 Mar;40(3):335-343. doi: 10.1097/MAO.0000000000002105.
• 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.
• Nelissen RC, den Besten CA, Mylanus EA, Hol MK. Stability, survival, and tolerability of a 4.5-mm-wide bone-anchored hearing implant: 6-month data from a randomized controlled clinical trial. Eur Arch Otorhinolaryngol. 2016 Jan;273(1):105-11. doi: 10.1007/s00405-015-3593-x. Epub 2015 Mar 20. Erratum In: Eur Arch Otorhinolaryngol. 2016 Jan;273(1):113-4. doi: 10.1007/s00405-015-3798-z.
• Vijverberg MA, Caspers CJI, Kruyt IJ, Mylanus EAM, Hol MKS. Prospective 5 year outcomes of different implant designs and surgical techniques in 68 patients with bone anchored hearing implants. Clin Otolaryngol. 2023 Jan;48(1):65-69. doi: 10.1111/coa.13974. Epub 2022 Sep 17. No abstract available.
• Kruyt IJ, Nelissen RC, Mylanus EAM, Hol MKS. Three-year Outcomes of a Randomized Controlled Trial Comparing a 4.5-mm-Wide to a 3.75-mm-Wide Titanium Implant for Bone Conduction Hearing. Otol Neurotol. 2018 Jun;39(5):609-615. doi: 10.1097/MAO.0000000000001761.

Study record dates

Study Major Dates

• Study Start (Actual): November 4, 2024
• Primary Completion (Estimated): March 31, 2025
• Study Completion (Estimated): March 31, 2025

Study Registration Dates

• First Submitted: December 20, 2024
• First Submitted That Met QC Criteria: January 9, 2025
• First Posted (Actual): March 25, 2025

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: January 15, 2025
• Last Verified: January 1, 2025

More Information

Terms related to this study

• Keywords: Hearing loss; Deafness; Implant survival; Ponto Wide implant; Oticon; 10 years; Hearing disorders
• Other Study ID Numbers: 2024-17533

Plan for Individual participant data (IPD)

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

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No