At a glance
- What the study gets you
- Access to the study treatment being tested
- Type of study
- Interventional (receives a drug or procedure)
- Time in hospital
- In-person visits at study sites — visit count not specified by the sponsor
- Drug or intervention
- ECochG monitored CI surgery incl. corrective action guide (procedure), Routine CI surgery without ECochG monitoring (procedure)
- How long the study runs
- Study runs about 31 months (dates as stated)
- About the drug or intervention
- ECochG monitored CI surgery incl. corrective action guide — procedure: Interventional surgery with surgeon having access to intra-operative ECochG monitoring feedback to deploy ECochG based corrective action guide · Routine CI surgery without ECochG monitoring — procedure: Routine CI surgery with access to ECochG monitoring by surgeon
- Patient visit burden
- Not specified by the sponsor
In plain English
This study, run by Advanced Bionics AG, looks at people with severe to profound hearing loss (a type called sensorineural hearing loss) who are having a cochlear implant. It is about preserving hearing and inner ear structure during implant surgery using something called ECochG (electrocochleography), which measures the ear's natural signals.
Who can take part
- Aged 18 or over
- Meets local rules for having a cochlear implant at the time of surgery
- Severe to profound hearing loss (average unaided hearing threshold of 70 decibels or worse) in the ear being implanted, across four sound pitches
- Hearing at 500 Hz (a low pitch) in the implanted ear is no worse than 70 decibels
- Has had severe to profound deafness in that ear for less than 15 years
- Hearing loss happened after learning to speak
- Normal inner ear (cochlea) shape shown by scans before surgery
- Due to receive an Advanced Bionics HiRes Ultra (3D) HiFocus SlimJ electrode (the implant part placed in the inner ear)
- Having cochlear implant surgery under general anaesthesia (being put to sleep)
- Fluent in the local language
- Has given informed consent to take part
Who may not be able to
- Unusual inner ear shape, including hardening or blockage (ossification), seen on scans
- Existing inner ear or middle ear problems, such as otosclerosis, cholesteatoma, or past middle ear surgery in that ear
- Medical conditions that raise the risk of problems during surgery, such as autoimmune diseases or active infections in the area
- Auditory spectrum neuropathy disorder (a problem with how hearing signals travel)
- Deafness caused by damage to the hearing nerve or brain hearing pathways
- Deafness caused by meningitis
- Single-sided deafness (hearing in the better ear is 30 decibels or better on average)
- Asymmetric hearing loss (hearing in the better ear is better than 30 decibels but not better than 55 decibels on average)
- Previous cochlear implant surgery on either ear
- Cannot have computed tomography (CT) scans for any reason
- Taking part in other cochlear implant studies at the same time
What taking part involves
- • Cochlear implant surgery under general anaesthesia
- • An Advanced Bionics HiRes Ultra (3D) device with a HiFocus SlimJ electrode is placed in the inner ear
- • ECochG (electrocochleography) is used during the process to help monitor hearing and inner ear structure — further details Not stated — ask the trial team
Time commitment: Not stated — ask the trial team
Plain-English summary (AI-generated) from registry data. Not eligibility advice — only the trial team can confirm whether you can take part. Use the eligibility checker to see how your health profile matches this trial.
- Type of study
- Testing a treatment
- Ages
- 18 Years and over
- Who
- All
- Number of participants
- 102
- Started
- 2024-05-15
- Last checked
- 2026-01
Plain English Summary
What is this study?
- • Testing a new treatment for hearing loss, sensorineural
- • NA - 102 participants
- • 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
Who can take part?
- • Ages 18 Years and over
- • Diagnosed with hearing loss, sensorineural
Where?
- • Cambridge - Cambridge University Hospitals NHS Foundation Trust
This is a simplified summary. Always discuss with your doctor before making any decisions.
About This Trial
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.
More detail
Cochlear implantation is a highly effective method of rehabilitating hearing in individuals with severe to profound hearing loss. One current hurdle to optimising hearing outcomes following cochlear implantation is the unavoidable trauma caused to the inner ear during implant surgery. This damage can mean residual hearing that would remain valuable following implantation is lost. Various approaches have been trialed to preserve hearing during implantation surgery, modifying implantation technique and administering steroids. Electrocochleography (ECochG) is a monitoring technique that can be used during electrode insertion to record inner ear structural integrity and function. The PRESERVE trial is an international, multi-centre, randomised controlled trial. The trial will randomly allocate adult cochlear implant recipients to undergo implantation surgery either with ECochG-guidance, or via the standard approach without guidance. Participants will be blinded, meaning they will not know which group they will be allocated to. Where ECochG is used, evidence of damage during insertion detected with the monitoring will trigger the surgeon to follow a corrective pathway. All other aspects of surgery and post operative care will follow standard clinical pathways for both groups. Participants will have their natural hearing measured preoperatively, and 3- and 6-months following implant activation. The change in natural hearing thresholds at different frequencies, and the degree of hearing preservation will then be calculated and compared between the standard surgery and ECochG-guided group. Using their cochlear implant, understanding of speech will also be measured and compared between groups. In addition, participants will undergo a second CT scan following implantation surgery, and this will be compared to the routine pre-operative imaging to assess both the location of the implant electrode, and structural preservation of the cochlear. Throughout the study participants will remain under the care of their routine medical team.
How this trial compares with your answers
Answer 2 more questions to improve match
What we know so far
Still need:
- • Tell us your age for better matching
- • Tell us your sex for better matching
Preliminary match based on your answers. Full eligibility requires on-site assessment including medical history, physical exam, and lab tests. This does not guarantee enrolment.
Eligibility at a Glance
Key info
- Age: 18 Years and over
- Who can join: All genders
What the study is looking for
- ✓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...
- ✓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
Who cannot take part
- ✗Abnormal cochlear anatomy (including ossification) as identified by pre-operative radiological evaluation in the ear...
- ✗Any pre-existing cochlear or middle ear pathology, such as otosclerosis, cholesteatoma, or previous middle ear...
- ✗Any medical conditions that would increase the risk of local complications during cochlear implantation, such as...
- ✗Diagnosis of auditory spectrum neuropathy disorder
- ✗Deafness due to lesions of the acoustic nerve or central auditory pathway
See the full criteria
Where Is This Study? (1 UK site)
Cambridge University Hospitals NHS Foundation Trust
Cambridge CB2 0QQ, United Kingdom
How to Get in Touch
Unai Martinez de Estibariz, Mr
Sponsor contactCONTACT
Martina Brendel, Ms
Sponsor contactCONTACT