Immediate loading of bone anchored hearing devices. Version 1

• Research type

  Research Study

• Full title

  Immediate loading of bone anchored hearing devices

• IRAS ID

  170335

• Contact name

  Kevin Green

• Contact email

  Kevin.Green@cmft.nhs.uk

• Sponsor organisation

  Central Manchester University Hospital NHS Foundation Trust

• Duration of Study in the UK

  1 years, 0 months, 1 days

• Research 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 5-10 years and patients are gaining access to their sound processor at a much earlier stage than when first brought onto the market.
  Despite this we 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 follow-up appointments patients will have the stability of their abutment checked and we will compare to see if loading earlier had any detrimental effects on ossteointegration 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

• REC name

  North West - Greater Manchester Central Research Ethics Committee

• REC reference

  15/NW/0154

• Date of REC Opinion

  13 Mar 2015

• REC opinion

  Favourable Opinion