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Guiding cochlear implant surgery with ear nerve signals in severe hearing loss

Tests signal-guided cochlear implant surgery against usual surgery in adults with severe hearing loss.

Key facts

Who runs it
Advanced Bionics AG
Where
Cambridge, United KingdomSee the siteAlso in 6 other countries, 6 sites
Trial code
Registry title
Hearing and Structure Preservation Via ECochG
Status
Recruiting
People taking part
102 people, planned
Started
15 May 2024
Expected to end
31 Dec 2026
Type of study
Interventional, 2 groupsOne group gets an existing treatment, for comparison.
Treatments tested
  • ECochG monitored CI surgery incl. corrective action guide
  • Routine CI surgery without ECochG monitoring
Record updated
6 January 2026

Who can take part

AI summary

From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.

The trial is looking for adults with severe to profound hearing loss who are listed for cochlear implant surgery. It compares surgery guided by ECochG, a test of the inner ear's electrical signals, with routine surgery.

Age
18 years or older
Sex
All sexes
Disease stage
Severe to profound sensorineural hearing loss in the ear to be implanted. The average unaided threshold is ≥ 70 dB HL at 500, 1000, 2000 and 4000 Hz. The threshold is ≤ 70 dB HL at 500 Hz. Severe to profound deafness in that ear has lasted less than 15 years. The hearing loss began after the person learned to speak. Imaging before surgery shows a normal inner ear (cochlea).
Earlier treatment
People who have had a cochlear implant before, or a new implant, in either ear cannot join. Previous middle ear surgery in the ear to be implanted is not allowed. People must be listed for an Advanced Bionics HiRes Ultra (3D) HiFocus SlimJ electrode array, with surgery under general anaesthesia.

Main reasons for not taking part

  • Abnormal inner ear shape, including bone growth inside it, or disease of the inner or middle ear such as otosclerosis or cholesteatoma
  • Auditory neuropathy, damage to the hearing nerve or brain hearing pathways, or deafness caused by meningitis
  • Deafness in one ear only, or uneven hearing loss (better ear average ≤ 55 dB HL)
  • Conditions that raise the risk of problems during surgery, such as autoimmune diseases or active local infections, or not being able to have CT scans
  • Taking part in other cochlear implant studies at the same time

The registry criteria, word for word

Show all 22 criteriaShow less

Who can take part

  • Aged 18 years of age or older
  • Within cochlear implant inclusion criteria by local regulations/guidelines at the time of implantation
  • Severe to profound hearing loss (average air conduction unaided hearing threshold of ≥ 70 dB HL for 500, 1000, 2000 and 4000 Hz) in the ear to be implanted
  • Air conduction unaided hearing threshold ≤ 70 dB HL at 500 Hz in the ear to be implanted
  • Less than 15 years of severe to profound deafness on the implant ear prior to surgery
  • Post-lingually acquired hearing loss in the ear to be implanted
  • Normal cochlear anatomy as confirmed by pre-operative imaging in the ear to be implanted
  • Listed for an Advanced Bionics HiRes Ultra (3D) HiFocus SlimJ electrode array
  • Listed for cochlear implant surgery under general anaesthesia
  • Fluent in local language
  • Given informed consent to participate in the study

Who cannot take part

  • Any pre-existing cochlear or middle ear pathology, such as otosclerosis, cholesteatoma, or previous middle ear surgery in the ear to be implanted
  • History of previous cochlear implantation/re-implantation on either ear
  • Concurrent participation in other cochlear implant related studies
  • Any medical conditions that would increase the risk of local complications during cochlear implantation, such as autoimmune diseases or active local infections
  • Diagnosis of auditory spectrum neuropathy disorder
  • Abnormal cochlear anatomy (including ossification) as identified by pre-operative radiological evaluation in the ear to be implanted
  • Deafness due to lesions of the acoustic nerve or central auditory pathway
  • Deafened by meningitis
  • Single sided deafness (average for 500, 1000, 2000 and 4000 Hz in the better ear ≤ 30 dB HL)
  • Asymmetric hearing loss (average for 500, 1000, 2000 and 4000 Hz in the better ear > 30 dB HL and ≤ 55 dB HL)
  • Any contraindications to computed tomography (CT) scans

Where in United Kingdom

Also in 6 other countries, 6 sites

  • Cambridge University Hospitals NHS Foundation TrustCambridge, United KingdomContact: Matthew E Smith, Dr (principal investigator)Taking people

About the trial

What the trial wants to find out

The goal of the study is to determine the benefit of using an ECochG-based corrective action guide during cochlear implant surgery compared to the traditional surgical approach without ECochG surveillance and guidance.

The 2 groups in the trial

  • InterventionTreatment being tested

    ECochG monitored CI surgery incl. corrective action guide

    Treatment: ECochG monitored CI surgery incl. corrective action guide

  • ControlExisting treatment, for comparison

    Routine CI surgery without ECochG monitoring

    Treatment: Routine CI surgery without ECochG monitoring

Questions to ask the study team

  1. How often do I need to come in, and for how long each time?
  2. Are travel costs paid?
  3. Can I keep my own doctor?
  4. What happens if I want to stop?

Contact the study team: see the registry record → Contacts and Locations

Print a page for my doctor

Data and sources

Registry record
Listed on ClinicalTrials.gov.
Official title
Preservation of Hearing and Structure Using an Electrocochleography Based Corrective Action Guide
Plain-language title
Guiding cochlear implant surgery with ear nerve signals in severe hearing lossGenerated from the registry record. The registry title is the official one.
AI summary
From the trial's eligibility criteria. Read by machine on 14 November 2026.
Record updated
6 January 2026