Naida M90 Sound Processor Remote Evaluation

  • Research type

    Research Study

  • Full title

    Remote Evaluation of the Naida CI M90 Sound Processor

  • IRAS ID

    292396

  • Contact name

    Patrick Axon

  • Contact email

    praxon@talk21.com

  • Sponsor organisation

    Cambridge University Hospital NHS Foundation Trust

  • Clinicaltrials.gov Identifier

    NCT05007886

  • Duration of Study in the UK

    1 years, 0 months, 1 days

  • Research summary

    This study will investigate a new cochlear implant (CI) sound processor, the Naida CI M90, (Naida-M) which has just been made available by the manufacturer. Typically every five years CI manufacturers update their sound processor models, making new features available without there being any need to disturb the implanted part. This NaidaM is based around technology that has already been made available to users of acoustic hearing aids.
    The Naida-M will replace the Naida-Q version that has been in use this past five or six years. Before making the Naida-M available generally, it is desirable to try it out on a small number of implant users. This will ensure that there are no odd behaviours found that need to be taken into account when dealing with a broader group of implant recipients
    Evaluation of the processor will involve remote testing of speech understanding in quiet and in noise using standard clinical tests, subjective feedback on the sound quality for a set of listening situations that reflect everyday use, and a questionnaire about how easy or difficult the new processor is to use during a take-home period of around two weeks.

    All components tested have received their CE mark and are being used for the purpose they were approved. Those asked to participate in the study will be due a processor upgrade. This means that they will not have to hand back the processor at the end of the study.

  • REC name

    HSC REC B

  • REC reference

    21/NI/0088

  • Date of REC Opinion

    5 May 2021

  • REC opinion

    Favourable Opinion