Immediate Loading of Bone Anchored Hearing Devices

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

Study Overview

• Status: Completed
• Conditions: Hearing Loss
• Intervention / Treatment: Device: Baha sound processor BA400

• Study Type: Interventional
• Enrollment (Actual): 1
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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)	Device: Baha sound processor BA400; Baha sound processor BA400 is a cochlear implant designed specifically for soft tissue preservation.
Experimental: 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)	Device: Baha sound processor BA400; Baha sound processor BA400 is a cochlear implant designed specifically for soft tissue preservation.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Compare device stability and rate of successful implantation	Measuring device stability and rate of successful implantation for patients fitted with the Baha BA400 immediately on the day of surgery and at fitting 2 weeks post operatively. A successful implant is an implant that osseointegrates and is stable over time when supporting the load of the Baha sound processor.	12 months

Secondary Outcome Measures

Outcome Measure	Time Frame
Measure the stability, as determined by Implant Stability Quotient (ISQ) values, of Baha implants placed immediately and at 23 weeks post operatively.	23 weeks
Record implant survival over time.	12 months
Monitor the status of the periimplant soft tissue using the classification proposed by Holgers' et al.	12 months

Collaborators and Investigators

• Sponsor: Manchester University NHS Foundation Trust
• Collaborators: Northern Care Alliance NHS Foundation Trust

Study record dates

Study Major Dates

• Study Start (Actual): June 1, 2016
• Primary Completion (Actual): June 1, 2017
• Study Completion (Actual): December 31, 2017

Study Registration Dates

• First Submitted: October 22, 2020
• First Submitted That Met QC Criteria: October 27, 2020
• First Posted (Actual): November 2, 2020

Study Record Updates

• Last Update Posted (Actual): April 25, 2023
• Last Update Submitted That Met QC Criteria: April 24, 2023
• Last Verified: April 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Nervous System Diseases; Neurologic Manifestations; Otorhinolaryngologic Diseases; Ear Diseases; Sensation Disorders; Hearing Disorders; Hearing Loss
• Other Study ID Numbers: R03963

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