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.

Study Overview

• Status: Completed
• Conditions: Hearing Loss; Conductive Hearing Loss; Atresia
• Intervention / Treatment: Device: Bone Achored Hearing surgery

• Study Type: Observational
• Enrollment (Actual): 15

Contacts and Locations

Study Locations

• Sweden
  • Stockholm, Sweden, 14186
    • Karolinska University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 2 years to 18 years (Child, Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Pediatric patients eligible for a bone anchored solution.

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Treatment; Bone Anchored Hearing surgery using a BHX implant manufactured by Oticon Medical	Device: Bone Achored Hearing surgery; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Stability 12 months	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.	12 months post surgery

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Stability 24 months	Difference in mean of ISQ low at 24 months compared to surgery	24 months post surgery
Implant survival rate	Implant survival rate in percent compared to litterature	24 months post surgery
Performance audibility PTA4	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.	1 month post surgery
Performance audibility	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	1 month post surgery
Performance speech intelligibility	Difference between abutment-aided and softband-aided speech intelligibility in SNR in preoperative condition and at fitting.	1 month post surgery
Functional assessment	Functional assessment as measured by change in Pediatric Evaluation of Aural/Oral Performance of Children (PEACH)	12 months, 24 months
Skin conditions Holger	Skin assessment as assessed with maximum Holgers score per patient. Maximum score 4. 0= no adverse skin reaction, 4=maximum adverse skin reaction.	7-10 days,12 months, 24 months post surgery
Skin conditions IPS evaluation	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	7-10 days,12 months, 24 months post surgery
Sustainability of audibility PTA4 performance	Difference between abutment aided sound field PTA 4 over time	1 month, 12 months, 24 months post surgey
Sustainability of audibility performance	Difference between abutment aided sound field Pure Tone thresholds at frequencies 500, 1000, 2000, 4000, 6000 and 8000 Hz over time	1 month, 12 months, 24 months post surgey
Sustainability of speech intelligibility performance	Difference between abutment aided speech intelligibility over time	1 month, 12 months, 24 months post surgey

Collaborators and Investigators

• Sponsor: Oticon Medical
• Collaborators: Karolinska University Hospital

Study record dates

Study Major Dates

• Study Start (Actual): September 4, 2018
• Primary Completion (Actual): January 10, 2023
• Study Completion (Actual): January 31, 2024

Study Registration Dates

• First Submitted: October 24, 2018
• First Submitted That Met QC Criteria: October 26, 2018
• First Posted (Actual): October 29, 2018

Study Record Updates

• Last Update Posted (Actual): October 31, 2024
• Last Update Submitted That Met QC Criteria: October 29, 2024
• Last Verified: October 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neurologic Manifestations; Nervous System Diseases; Otorhinolaryngologic Diseases; Sensation Disorders; Ear Diseases; Hearing Disorders; Hearing Loss; Deafness; Hearing Loss, Conductive
• Other Study ID Numbers: C64

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No