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

NCT03723161 | Completed

• 1 other identifier: C64
• Study Type: observational
• Target: 15
• Locations: 1 country
• Sites: 1

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.

Conditions

Hearing Loss; Conductive Hearing Loss; Atresia

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (11)

• Stability 24 months

  24 months post surgery

• Implant survival rate

  24 months post surgery

• Performance audibility PTA4

  1 month post surgery

• Performance audibility

  1 month post surgery

• Performance speech intelligibility

  1 month post surgery

Study Arms (1)

Treatment

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

Device: Bone Achored Hearing surgery

Interventions

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.

Treatment

Eligibility Criteria

• Age: 30 Months - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

Pediatric patients eligible for a bone anchored solution.

You may qualify if:

• 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

You may not qualify if:

• Not fluent in Swedish or English; subject and/or legal guardian
• Unwillingness to participate in follow up visits

Sponsors & Collaborators

• Oticon Medical: lead
• Karolinska University Hospital: collaborator

Study Sites (1)

Karolinska University Hospital

Stockholm, 14186, Sweden

Location

MeSH Terms

Conditions

Hearing Loss; Hearing Loss, Conductive

Condition Hierarchy (Ancestors)

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

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 24, 2018
• First Posted: October 29, 2018
• Study Start: September 4, 2018
• Primary Completion: January 10, 2023
• Study Completion: January 31, 2024
• Last Updated: October 31, 2024

Record last verified: 2024-10

Data Sharing

• IPD Sharing: Will not share

Locations

SE (1)