Evaluation of the Ponto Bone Anchored Hearing System in a Pediatric Atresia Population

Last updated: October 29, 2024
Sponsor: Oticon Medical
Overall Status: Completed

Phase

N/A

Condition

Hearing Loss

Deafness

Hearing Impairment

Treatment

Bone Achored Hearing surgery

Clinical Study ID

NCT03723161
C64
  • Ages 30-18
  • All Genders

Study Summary

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

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Patients who have decided to undergo a Bone Anchored Hearing Surgery

  • Diagnosed with atresia

  • Signed informed consent

  • Patients between 2,5 - 18 years of age

  • Patients eligible for one stage surgery

Exclusion

Exclusion Criteria:

  • Not fluent in Swedish or English; subject and/or legal guardian

  • Unwillingness to participate in follow up visits

Study Design

Total Participants: 15
Treatment Group(s): 1
Primary Treatment: Bone Achored Hearing surgery
Phase:
Study Start date:
September 04, 2018
Estimated Completion Date:
January 31, 2024

Connect with a study center

  • Karolinska University Hospital

    Huddinge, 14157
    Sweden

    Site Not Available

  • Karolinska University Hospital

    Stockholm, 14186
    Sweden

    Site Not Available

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