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

Learn more about:
Related Clinical Trial
Subject´s Preference Regarding Hearing Performance and Functionality Using a New Sound Processor Evaluation of the Ponto Bone Anchored Hearing System in a Pediatric Atresia Population Evaluation of Sound Processor for a Transcutaneous System Evaluation of the Effectiveness of Bone-anchored Hearing Aids (Baha) Clinical Survey of Different Abutment Topologies Clinical Survey of Oticon Medical Healing Cap Clinical Survey of Oticon Medical Ponto Implants and a Surgical Technique With Tissue Preservation Quality of Life With Bone Conduction Hearing Device Comparison of a New Bone Conduction Hearing System to a Osteo-integrated Bone Conduction Hearing Aid on a Softband Long Term Stability, Survival and Tolerability of a (Novel) Baha® Implant System Hearing for Learning Initiative – a Health Facilitator Model for Otitis Media Audiological Benefit and Quality of Life With Two Bone Conduction Systems: ADHEAR vs. Contact Mini SoundBite Hearing System Long Term Multi Site Patient Use Study SoundBite Hearing System 24 Month Multi Site Patient Use Study Montelukast for Children With Chronic Otitis Media With Effusion (COME): A Double-blind, Placebo-controlled Study Ambispective Clinical Evaluation of Sophono™ The Influence of The Ear Popper on Serous Otitis Media and on the Accompanying Conductive Hearing Loss in Children Use of ADHEAR, a Non-Implantable Bone Conduction Hearing System, in Children With Single Sided Deafness and/or Conductive Hearing Loss Osia CPT Code Study The Anatomic Determinants of Perforation Induced Hearing Loss

Brief Title

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

Official Title

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

Brief 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.
    



Study Type

Observational


Primary Outcome

Stability 12 months

Secondary Outcome

 Stability 24 months

Condition

Hearing Loss

Intervention

Bone Achored Hearing surgery

Study Arms / Comparison Groups

 Treatment
Description:  Bone Anchored Hearing surgery using a BHX implant manufactured by Oticon Medical

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information


Recruitment Status

Device

Estimated Enrollment

15

Start Date

September 4, 2018

Completion Date

March 4, 2021

Primary Completion Date

March 4, 2020

Eligibility Criteria

        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 Criteria:

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

          -  Unwillingness to participate in follow up visits
      

Gender

All

Ages

30 Months - 18 Years

Accepts Healthy Volunteers

No

Contacts

, 0046702777332, [email protected]

Location Countries

Sweden

Location Countries

Sweden

Administrative Informations


NCT ID

NCT03723161

Organization ID

C64


Responsible Party

Sponsor

Study Sponsor

Oticon Medical

Collaborators

 Karolinska University Hospital

Study Sponsor

, , 


Verification Date

April 2019