Evaluation of the BHX Implant in Children with a BAHS

NCT03742089 | Completed

• 1 other identifier: C52
• Study Type: observational
• Target: 15
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to in a proactive manner collect high quality data from pediatric patients who have undergone a bone anchored hearing surgery, using the Ponto BHX implant, in clinical practice. This to further increase the knowledge of bone anchored hearing systems in the pediatric population.

Conditions

Hearing Loss, Conductive

Outcome Measures

Primary Outcomes (1)

• Implant stability

  Implant stability will be assessed using resonance frequency analysis (RFA). This is a non-invasive technique using a SmartPeg (no 55) introduced into the abutment top. A probe is directed to the SmartPeg measuring the vibrations as a test for the stability of the interface between the fixture and the bone (osseointegration). The measurement renders Implant Stability Quotient (ISQ) 'numerical values from 1 to 100'; the higher the ISQ value, the higher the stability. Two perpendicular measurements will be performed at each site. The highest and lowest ISQ value obtained at each time point aree recorded. The Osstell ISQ instrument and SmartPegs from Osstell (Gothenburg, Sweden) will be used. Difference in mean of ISQ low at 6 months compared to surgery.

  6 months post surgery

Study Arms (1)

Treatment

Bone Anchored Hearing Surgery using a BHX implant manufactured by Oticon Medical

Device: Bone Anchored Hearing Surgery

Interventions

Bone Anchored Hearing Surgery DEVICE

This is a observational study of pediatric patients undergoing bone anchored hearing surgery. The collected will be used to assess the implant stability development of the Ponto BHX implant during up to 24 months after implantation in a pediatric population undergoing BAHS. The study will also monitor the Ponto BHX implant safety and survival throughout the study period.

Treatment

Eligibility Criteria

• Age: 5 Years - 16 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)
• Sampling Method: Non-Probability Sample

Study Population

Pediatric population eligible for a bone anchored hearing surgery

You may qualify if:

• Patients who have decided to undergo a Bone Anchored Hearing Surgery and receive a Ponto system.
• Signed informed consent.
• Patients between 5 - 16 years of age.
• Patients eligible for one stage surgery.
• Patients who have been using Ponto sound processor on a soft band for at least 2 weeks.

You may not qualify if:

• Patients who cannot attend follow up visits.
• Patients with single side deafness (SSD).
• In surgeon's opinion, any other disorder and condition that may deem the patient unfit to participate in the study.
• Patients who receive other implant than the Ponto BHX.

Sponsors & Collaborators

• Oticon Medical: lead

Study Sites (1)

The James Cook University Hospital

Middlesbrough, TS4 3BE, United Kingdom

Location

MeSH Terms

Conditions

Hearing Loss, Conductive

Condition Hierarchy (Ancestors)

Hearing Loss; Hearing Disorders; Ear Diseases; Otorhinolaryngologic Diseases; Sensation Disorders; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 24, 2018
• First Posted: November 15, 2018
• Study Start: May 22, 2018
• Primary Completion: June 14, 2023
• Study Completion: September 22, 2024
• Last Updated: October 31, 2024

Record last verified: 2024-10

Locations

GB (1)