Update on the National Registry for Hearing Implants – March 2025
It has been a very busy year for the NRHI steering group, with significant progress being made towards our eventual goal of a registry for all implanted hearing devices. The primary aim of the registry remains to improve safety and outcomes for hearing implant users in the UK.
Launch!!
The CI arm of the Registry finally ‘went live’ on Monday 24th March 2025 for five early adopter sites (St Thomas’, NECIP, Cambridge, Birmingham Adults and Childrens)
The remainder of English CI centres will ‘go live’ on 8th May, with all centres entering their data by 8th June 2025. Launch for the devolved Nations remains pending.
Full training will be provided; NRHI training webinars and resources are available in the BCIG members area.
Background
The NRHI has been developed under the NHS England ‘Outcomes Registry Programme’ (ORP). This overarching National programme aims to capture key data on all types of implanted medical devices. The data collected by the ORP is on two levels. Firstly a single ‘core dataset’ for all implantable medical devices, which will cover details of the device used (including unique device identifier or UDI), patient, date & place of surgery and surgeon. When standing alone, this element is also known as ‘MDOR’, or the Medical Device Outcome Registry. Secondly, individual specialties may set up additional outcome datasets, with clinical information relevant to the specific type of device.
For the NRHI a suite of outcome datasets have been developed for cochlear implants - these include relevant clinical information, complications, and in future will include patient-reported outcomes (PROMs and PREMs). Other registries being developing in parallel with the NRHI include neural implants, breast and cosmetic implants and pelvic floor implants.
Trusts in England have already received notice that they are required to complete core ‘MDOR’ datasets for all type IIb and III medical devices. This will include cochlear implants, ABI, active bone conduction implants and MEI (as type III) and other bone conduction implants (as type IIb). The ORP have funded development of a national online portal for data submission. They will also support ongoing data analysis and reporting.
Progress to date
In order to progress work on the NRHI, Katherine Wilson, Kate Hanvey, Debi Vickers, Jenny Townsend and Dan Jiang have been working closely with NHSE, ORP, and NEC (the registry software provider) to provide expert clinical input. We have now completed User Test Acceptance for the Registry dataset and data-entry portal, ready for rollout from March 2025. Final governance approvals were obtained in Feb 2025 to allow collection of data without consent, for NHS patients in England.
A manual/handbook and training resources to support registry users are available, including a series of webinars supported by live Q&As. We understand that each site will have their own optimal process for entering registry data, so will aim to provide flexible support, including on the use of barcode scanners or paper proformas if required.
We have also begun work on widening patient engagement into the ongoing registry development, utilising the new BCIG PPIE group. Our first focus group activity took place last year focussed on patient views on the options for adult PROMs. A second group will consider paediatric PROMs.
NHSE and the NRHI steering group are currently actively engaging with the Welsh, Scottish and Northern Irish governments to explore alignment, governance and data sharing arrangements for the NHRI and the wider outcome registries programme.
Next Steps
Once the first data is being collected, work will begin on data analysis and reporting. A committee has been established for reporting and outlier analysis, led by Debi Vickers. Centres will be able to access their own data, with a series of regular published reports produced for the public domain. There will be patient/service user involvement at all stages of this process.
Datasets for the ABI and BCHI/MEI implant types are due for consultation shortly. Work will begin on extending the platform to collect this data, and to engage with ‘BCHI only’ sites in England to ensure good compliance with data entry.
Patient reported outcomes (PROMs and PREMs) will follow shortly; the intention is that the registry system will contact patients automatically by email at defined intervals and ask patients to submit their responses into an online portal e.g. via their mobile phone. Missing responses can be automatically ‘chased’ by the registry if required. Response by post will also remain an option for those who do not wish to engage digitally.
Future developments
Longer term, the NRHI steering group will change focus towards data quality monitoring and development of clinical outcome.
We hope to achieve integration of the portal with Auditbase to pull through some clinical data automatically, in order to reduce the load on clinicians. We are also exploring the possibility of linking the registry to manufacturers and/or MHRA, to allow a single point of device registration.
Keep in touch: please feel free to email Katherine, Kate, Jenny, Debi or Dan if you have any registry-related questions or comments!
Katherine.Wilson@gstt.nhs.uk
Katehanvey@nhs.net
dav1000@medschl.cam.ac.uk
Jenny.townsend@wales.nhs.uk
Dan.jiang@gstt.nhs.uk