Designing a Trial of Bilateral Cochlear Implantation in Adults

Summary

In the UK, cochlear implantation is the standard treatment for adults with 'severe-to-profound' deafness. This level of deafness means that without a cochlear implant they have difficulty understanding what people are saying even when they wear hearing aids. The NHS provides a cochlear implant for one ear even though these adults are deaf in both ears. Two cochlear implants could help them understand speech in noisy environments, know where to look to see who is talking, and avoid hazards outdoors.

The decision about who can receive cochlear implants and how many they can receive is based on guidance from the National Institute for Health and Care Excellence (NICE). NICE agreed that providing two cochlear implants can provide additional benefits over providing just one implant. However, they decided that there is not enough evidence to show that these additional benefits are worth the additional cost of providing the second implant. NICE recommended that a clinical trial should be conducted to gather this evidence.

This study will consult with patients to explore whether the trial would be acceptable to future implant recipients. The study will also work with clinicians to design a trial comparing bilateral and unilateral implantation in adults. These clinicians will also be surveyed to assess the acceptability of the trial. A group of clinicians that span the range of professions involved in delivering the care pathway will be invited to attend a trial design workshop to establish a consensus on acceptable trial design elements from a clinical perspective. Representatives from cochlear implant manufacturers will be consulted to determine possible strategies for securing industry support for a future trial. Those who run cochlear implantation services will be engaged in a working group to gather information on the current care pathway to inform future assessments of whether bilateral implantation could be cost-effective.

Conditions

• Hearing Loss, Bilateral
• Hearing Loss, Sensorineural

Interventions

OTHER

No intervention

No intervention will be administered to any group in this observational study.

Sponsors & Collaborators

• National Institute for Health Research, United Kingdom

  collaborator OTHER_GOV

• University of Nottingham

  collaborator OTHER

• University of Liverpool

  collaborator OTHER

• University of Southampton

  collaborator OTHER

• University of East Anglia

  collaborator OTHER

• National Cochlear Implant Users Association, United Kingdom

  collaborator UNKNOWN

• Nottingham University Hospitals NHS Trust

  lead OTHER

Principal Investigators

• Padraig T Kitterick, PhD · University of Nottingham

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2017-06-14

Primary Completion

2019-08-02

Completion

2019-08-02

Countries

• United Kingdom

Study Locations