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Completed

NCT Number: NCT03723161

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

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.

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Key information

Conditions

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

Age range

30 month–18 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Karolinska University Hospital

Stockholm, 14186, Sweden

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Bone Achored Hearing surgery

Device

This is a observational study of pediatric patients undergoing bone anchored hearing surgery. The collected data will be used to assess the implant stability development of the Ponto BHX implant during up tp 24 months after implantation in a pediatric population undergoing bone anchored hearing surgery.

Primary outcomes

  1. Stability 12 months

    Time frame: 12 months post surgery

    The development of implant stability during the first 12 months after implantation; as measured by difference in mean of (Implant Stability Quotient) ISQ low 12 months compared to surgery.

Secondary outcomes

  1. Stability 24 months

    Time frame: 24 months post surgery

    Difference in mean of ISQ low at 24 months compared to surgery

  2. Implant survival rate

    Time frame: 24 months post surgery

    Implant survival rate in percent compared to litterature

  3. Performance audibility PTA4

    Time frame: 1 month post surgery

    The difference between abutment-aided and softband-aided sound field Pure Tone Average of thresholds at frequencies 500, 1000, 2000 and 4000 Hz (PTA 4) in preoperative condition and at fitting.

  4. Performance audibility

    Time frame: 1 month post surgery

    Difference between abutment-aided and softband-aided sound field Pure Tone thresholds at frequencies 500, 1000, 2000, 4000, 6000 and 8000 Hz) in preoperative condition and at fitting

  5. Performance speech intelligibility

    Time frame: 1 month post surgery

    Difference between abutment-aided and softband-aided speech intelligibility in SNR in preoperative condition and at fitting.

  6. Functional assessment

    Time frame: 12 months, 24 months

    Functional assessment as measured by change in Pediatric Evaluation of Aural/Oral Performance of Children (PEACH)

  7. Skin conditions Holger

    Time frame: 7-10 days,12 months, 24 months post surgery

    Skin assessment as assessed with maximum Holgers score per patient. Maximum score 4. 0= no adverse skin reaction, 4=maximum adverse skin reaction.

  8. Skin conditions IPS evaluation

    Time frame: 7-10 days,12 months, 24 months post surgery

    Skin condition as assessed by (Inflammation, Pain, Skin height/numbness (IPS) score. I scale randing from 0-4, Pain scale ranging from 0-2, Height scale ranging from 0-2. Total score 8, 0=no adverse skin reaction, 8=maximum adverse skin reaction

  9. Sustainability of audibility PTA4 performance

    Time frame: 1 month, 12 months, 24 months post surgey

    Difference between abutment aided sound field PTA 4 over time

  10. Sustainability of audibility performance

    Time frame: 1 month, 12 months, 24 months post surgey

    Difference between abutment aided sound field Pure Tone thresholds at frequencies 500, 1000, 2000, 4000, 6000 and 8000 Hz over time

  11. Sustainability of speech intelligibility performance

    Time frame: 1 month, 12 months, 24 months post surgey

    Difference between abutment aided speech intelligibility over time

Sponsors and collaborators

Lead sponsor

Oticon Medical

Industry

Collaborators

  • Karolinska University Hospital

Registry information

Important dates

Study start
2018
Primary completion
2023
Study completion
2024
First posted
Oct 29, 2018
Registry last updated
Oct 31, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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