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Immediate Loading of Bone Anchored Hearing Devices

Primary Purpose

Hearing Loss

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Baha sound processor BA400
Sponsored by
Manchester University NHS Foundation Trust
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Hearing Loss

Eligibility Criteria

18 Years - 110 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Experimental

    Arm Label

    Immediate loading group

    2-week loading group

    Arm Description

    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)

    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)

    Outcomes

    Primary Outcome Measures

    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.

    Secondary Outcome Measures

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

    Full Information

    First Posted
    October 22, 2020
    Last Updated
    April 24, 2023
    Sponsor
    Manchester University NHS Foundation Trust
    Collaborators
    Northern Care Alliance NHS Foundation Trust
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    1. Study Identification

    Unique Protocol Identification Number
    NCT04611698
    Brief Title
    Immediate Loading of Bone Anchored Hearing Devices
    Official Title
    Immediate Loading of Bone Anchored Hearing Devices
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    April 2023
    Overall Recruitment Status
    Completed
    Study Start Date
    June 2016 (Actual)
    Primary Completion Date
    June 2017 (Actual)
    Study Completion Date
    December 31, 2017 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Manchester University NHS Foundation Trust
    Collaborators
    Northern Care Alliance NHS Foundation Trust

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No

    5. Study Description

    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

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Hearing Loss

    7. Study Design

    Primary Purpose
    Supportive Care
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    None (Open Label)
    Allocation
    Non-Randomized
    Enrollment
    1 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Immediate loading group
    Arm Type
    Experimental
    Arm Description
    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)
    Arm Title
    2-week loading group
    Arm Type
    Experimental
    Arm Description
    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)
    Intervention Type
    Device
    Intervention Name(s)
    Baha sound processor BA400
    Intervention Description
    Baha sound processor BA400 is a cochlear implant designed specifically for soft tissue preservation.
    Primary Outcome Measure Information:
    Title
    Compare device stability and rate of successful implantation
    Description
    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.
    Time Frame
    12 months
    Secondary Outcome Measure Information:
    Title
    Measure the stability, as determined by Implant Stability Quotient (ISQ) values, of Baha implants placed immediately and at 23 weeks post operatively.
    Time Frame
    23 weeks
    Title
    Record implant survival over time.
    Time Frame
    12 months
    Title
    Monitor the status of the periimplant soft tissue using the classification proposed by Holgers' et al.
    Time Frame
    12 months

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    110 Years
    Accepts Healthy Volunteers
    No
    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

    12. IPD Sharing Statement

    Plan to Share IPD
    No

    Learn more about this trial

    Immediate Loading of Bone Anchored Hearing Devices

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