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OpenTrials
Completed

NCT Number: NCT04611698

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

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Key information

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Baha sound processor BA400

Device

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

Primary outcomes

  1. Compare device stability and rate of successful implantation

    Time frame: 12 months

    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 outcomes

  1. 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

  2. Record implant survival over time.

    Time frame: 12 months

  3. Monitor the status of the periimplant soft tissue using the classification proposed by Holgers' et al.

    Time frame: 12 months

Sponsors and collaborators

Lead sponsor

Manchester University NHS Foundation Trust

Other Gov

Collaborators

  • Northern Care Alliance NHS Foundation Trust

Registry information

Important dates

Study start
2016
Primary completion
2017
Study completion
2017
First posted
Nov 2, 2020
Registry last updated
Apr 25, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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