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Evaluation of the BHX Implant in Children with a BAHS

NCT03742089 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 15

Last updated 2024-10-31

No results posted yet for this study

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

Interventions

DEVICE

Bone Anchored Hearing Surgery

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.

Sponsors & Collaborators

  • Oticon Medical

    lead INDUSTRY

Eligibility

Min Age
5 Years
Max Age
16 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-05-22
Primary Completion
2023-06-14
Completion
2024-09-22

Countries

  • United Kingdom

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03742089 on ClinicalTrials.gov