Evaluation of the BHX Implant in Children With a BAHS

  • End date
    May 30, 2023
  • participants needed
  • sponsor
    Oticon Medical
Updated on 23 January 2021


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.

Condition Conductive hearing loss
Treatment Bone Anchored Hearing Surgery
Clinical Study IdentifierNCT03742089
SponsorOticon Medical
Last Modified on23 January 2021


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Inclusion Criteria

Is your age between 5 yrs and 16 yrs?
Gender: Male or Female
Do you have Conductive hearing loss?
Do you have any of these conditions: Do you have Conductive hearing loss??
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

Exclusion Criteria

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
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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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