Immediate Loading of Bone Anchored Hearing Devices

NCT ID: NCT04611698

Last Updated: 2023-04-25

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 1 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-06-30
• Study Completion Date: 2017-12-31

Brief Summary

Bone anchored hearing aids provide a hearing solution for patients that are unable to wear traditional air conduction hearing aid solutions. The technology of the devices has developed significantly over the last 510 years and patients are gaining access to their sound processor at a much earlier stage than when first brought onto the market. Despite this the investigators feel there is still room to develop this and with the new abutments with specialised hydroxyapatite coating it is hoped that patients can be loaded with their sound processor in the day of surgery. This study will compare abutment stability between two groups of patients. Those loaded immediately with their sound processor and those loaded traditionally at 2 weeks post operatively.

At routine followup appointments patients will have the stability of their abutment checked and the investigators will compare to see if loading earlier had any detrimental effects on osteointegration and the stability of the abutment.

Based on the favourable outcomes and high stability record for the BA400 it is anticipated that the time to processor fitting may be further reduced, provided favourable bone conditions at the implant site and provided satisfactory soft tissue status at the time of loading. It is hypothesised that loading immediately at the time of surgery is possible with comparable short and long term outcomes when compared to standard loading at 2 weeks

Conditions

Hearing Loss

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

Immediate loading group

Visit 1 Implant surgery + Device loading Baseline Visit 2 Followup examination 2 weeks (2/+ 5 days) Visit 3 Followup examination 3 months (± 1 week) Visit 4 Followup examination 6 months (± 1 week) Visit 5 Followup examination 12 months (± 1 month)

Group Type: EXPERIMENTAL

Baha sound processor BA400

Intervention Type: DEVICE

Baha sound processor BA400 is a cochlear implant designed specifically for soft tissue preservation.

2-week loading group

Visit 1 Implant surgery Baseline Visit 2 Device loading 2 weeks (2/+5 days) Visit 3 Followup examination 3 months (± 1 week) Visit 4 Followup examination 6 months (± 1 week) Visit 5 Followup examination 12 months (± 1 month)

Group Type: EXPERIMENTAL

Baha sound processor BA400

Intervention Type: DEVICE

Baha sound processor BA400 is a cochlear implant designed specifically for soft tissue preservation.

Interventions

Baha sound processor BA400

Baha sound processor BA400 is a cochlear implant designed specifically for soft tissue preservation.

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

• Patients eligible for receiving the Baha system.

Exclusion Criteria

• Adult patients, i.e. ≥18 years
• Eligible for the Baha system
• Bone thickness at the implant site of at least 4 mm
• No known disease or treatment that compromises / will compromise the bone quality at the implant site

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 110 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Northern Care Alliance NHS Foundation Trust

OTHER

Sponsor Role: collaborator

Manchester University NHS Foundation Trust

OTHER_GOV

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Other Identifiers

R03963

Identifier Type: -

Identifier Source: org_study_id