Hearing Loss, SensorineuralPRESERVENCT06268340
Hearing and Structure Preservation Via ECochG
A study testing ECochG monitored CI surgery incl. corrective action guide and Routine CI surgery without ECochG monitoring in people with Hearing Loss, Sensorineural and Severe-to-profound Hearing Loss, run by Advanced Bionics AG at 7 sites in 7 countries.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hearing Loss, Sensorineural, Severe-to-profound Hearing Loss
- What is being tested?
- ECochG monitored CI surgery incl. corrective action guide and Routine CI surgery without ECochG monitoring
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 102 participants
- Where
- 7 sitesin 7 countries
- Study dates
- 15 May 2024to 31 Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Show all 11Show fewer
- 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 join
- Abnormal cochlear anatomy (including ossification) as identified by pre-operative radiological evaluation in the ear to be implanted
- Any pre-existing cochlear or middle ear pathology, such as otosclerosis, cholesteatoma, or previous middle ear surgery in the ear to be implanted
- 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
- Deafness due to lesions of the acoustic nerve or central auditory pathway
- Deafened by meningitis
Show all 11Show fewer
- 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)
- History of previous cochlear implantation/re-implantation on either ear
- Any contraindications to computed tomography (CT) scans
- Concurrent participation in other cochlear implant related studies
Trial locations and contacts
7 sites in 7 countries. Contact the study team or a site near you to ask about taking part.
7 sites in 7 countries
Belgium1 site, 1 recruiting
- Recruiting
Universitair Ziekenhuis Gent
Ghent, Gent, 9000
Ingeborg Dhooge, Dr
Freya Swinnen, Dr
France1 site, 1 recruiting
- Recruiting
Le Centre Hospitalier Régional Universitaire de Tours
Tours, Tours, 37000
David Bakhos, Prof
Mathieu Robier, Mr
Germany1 site, 1 recruiting
- Recruiting
Universitätsklinikum Freiburg Klinik
Freiburg im Breisgau, Freiburg, 79106
Antje Aschendorff, Prof
Thomas Wesarg, Dr
Italy1 site, 1 recruiting
- Recruiting
Ospedale Martini
Torino, TO, 10141
Diego Di Lisi, Dr
Patrizia Consolino, Dr
Poland1 site, 1 recruiting
- Recruiting
World Hearing Center
Warsaw, Nadarzyn, 05-830
Piotr Skarżyński, Prof
Adam Walkowiak, Dr
Spain1 site, 1 recruiting
- Recruiting
Hospital Universitario Clinico San Cecilio
Granada, Granada, 18007
Nicolas Müller, Dr
Jose Pineda
United Kingdom1 site, 1 recruiting
- Recruiting
Cambridge University Hospitals NHS Foundation Trust
Cambridge, England, CB2 0QQ
Matthew E Smith, Dr
Patrick Axon, Dr
About this study
Official title: Preservation of Hearing and Structure Using an Electrocochleography Based Corrective Action Guide
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.
Read the detailed description
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.
- Being tested
- ECochG monitored CI surgery incl. corrective action guide, Routine CI surgery without ECochG monitoring
- Keywords
- Electrocochleography, Hearing Preservation, Structure Preservation, Intra-cochlear monitoring, Scalar translocations, Cochlear Microphonics, Corrective action guide, Cochlear Implants
- Medical subject headings
- Hearing Loss, Sensorineural
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ECochG monitored CI surgery incl. corrective action guideProcedure or surgery
Interventional surgery with surgeon having access to intra-operative ECochG monitoring feedback to deploy ECochG based corrective action guide
Routine CI surgery without ECochG monitoringProcedure or surgery
Routine CI surgery with access to ECochG monitoring by surgeon
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Experimental | ECochG monitored CI surgery incl. corrective action guide Receives: Procedure: ECochG monitored CI surgery incl. corrective action guide |
| Control | Active comparator | Routine CI surgery without ECochG monitoring Receives: Procedure: Routine CI surgery without ECochG monitoring |
What is being measured
The primary outcome is the main question the study is designed to answer.
Hearing Preservation
Difference in dB (absolute) and % (relative) in low-frequency hearing preservation measured via air conduction pure tone audiometry
Measured: From pre-operative to 6 months post-operative
Secondary outcomes (2)
Structure Preservation
Difference in mm of structure preservation (distance from electrode contact to basilar membrane) via radiological assessment of the position of the electrode array
Measured: 1 month post-operative
Speech perception
Difference in speech perception scores in both quiet (%) and noise (dB SNR) using the International Matrix Test
Measured: From pre-operative to 6 months post-operative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Feb 2024
- Study start15 May 2024
- Primary completion31 Dec 2026 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (12)Papers the sponsor has linked to this study.
- Other trials for Hearing Loss, SensorineuralStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 102 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Advanced Bionics AG
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Matt E Smith, Dr, Principal investigator, Cambridge University Hospitals NHS Foundation Trust
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06268340
- Sponsor's protocol ID
- ABIntl-23-25
- Acronym
- PRESERVE
- Status last verified
- Jan 2026
- First submitted
- 30 Jan 2024
- Last updated
- 6 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Bester C, Collins A, Razmovski T, Weder S, Briggs RJ, Wei B, Zakaria AF, Gerard JM, Mitchell-Innes A, Tykocinski M, Kennedy R, Iseli C, Dahm M, Ellul S, O'Leary S. Electrocochleography triggered intervention successfully preserves residual hearing during cochlear implantation: Results of a randomised clinical trial. Hear Res. 2022 Dec;426:108353. doi: 10.1016/j.heares.2021.108353. Epub 2021 Sep 20.
PubMed 34600798Buechner A, Bardt M, Haumann S, Geissler G, Salcher R, Lenarz T. Clinical experiences with intraoperative electrocochleography in cochlear implant recipients and its potential to reduce insertion trauma and improve postoperative hearing preservation. PLoS One. 2022 Apr 22;17(4):e0266077. doi: 10.1371/journal.pone.0266077. eCollection 2022.
PubMed 35452461Carlson ML, Driscoll CL, Gifford RH, Service GJ, Tombers NM, Hughes-Borst BJ, Neff BA, Beatty CW. Implications of minimizing trauma during conventional cochlear implantation. Otol Neurotol. 2011 Aug;32(6):962-8. doi: 10.1097/MAO.0b013e3182204526.
PubMed 21659922Dalbert A, Sim JH, Gerig R, Pfiffner F, Roosli C, Huber A. Correlation of Electrophysiological Properties and Hearing Preservation in Cochlear Implant Patients. Otol Neurotol. 2015 Aug;36(7):1172-80. doi: 10.1097/MAO.0000000000000768.
PubMed 25839980Koka K, Riggs WJ, Dwyer R, Holder JT, Noble JH, Dawant BM, Ortmann A, Valenzuela CV, Mattingly JK, Harris MM, O'Connell BP, Litvak LM, Adunka OF, Buchman CA, Labadie RF. Intra-Cochlear Electrocochleography During Cochear Implant Electrode Insertion Is Predictive of Final Scalar Location. Otol Neurotol. 2018 Sep;39(8):e654-e659. doi: 10.1097/MAO.0000000000001906.
PubMed 30113557Giardina CK, Brown KD, Adunka OF, Buchman CA, Hutson KA, Pillsbury HC, Fitzpatrick DC. Intracochlear Electrocochleography: Response Patterns During Cochlear Implantation and Hearing Preservation. Ear Hear. 2019 Jul/Aug;40(4):833-848. doi: 10.1097/AUD.0000000000000659.
PubMed 30335669Gifford RH, Dorman MF, Skarzynski H, Lorens A, Polak M, Driscoll CL, Roland P, Buchman CA. Cochlear implantation with hearing preservation yields significant benefit for speech recognition in complex listening environments. Ear Hear. 2013 Jul-Aug;34(4):413-25. doi: 10.1097/AUD.0b013e31827e8163.
PubMed 23446225Lenarz T, Timm ME, Salcher R, Buchner A. Individual Hearing Preservation Cochlear Implantation Using the Concept of Partial Insertion. Otol Neurotol. 2019 Mar;40(3):e326-e335. doi: 10.1097/MAO.0000000000002127.
PubMed 30741914O'Leary S, Mylanus E, Venail F, Lenarz T, Birman C, Di Lella F, Roland JT Jr, Gantz B, Beynon A, Sicard M, Buechner A, Lai WK, Boccio C, Choudhury B, Tejani VD, Plant K, English R, Arts R, Bester C. Monitoring Cochlear Health With Intracochlear Electrocochleography During Cochlear Implantation: Findings From an International Clinical Investigation. Ear Hear. 2023 Mar-Apr 01;44(2):358-370. doi: 10.1097/AUD.0000000000001288. Epub 2022 Nov 8.
PubMed 36395515Saoji AA, Patel NS, Carlson ML, Neff BA, Koka K, Tarigoppula VSA, Driscoll CLW. Multi-frequency Electrocochleography Measurements can be Used to Monitor and Optimize Electrode Placement During Cochlear Implant Surgery. Otol Neurotol. 2019 Dec;40(10):1287-1291. doi: 10.1097/MAO.0000000000002406.
PubMed 31644474Skarzynski PH, Lorens A, Walkowiak A, Polak M, Skarzynski H. Multi-Frequency Intraoperative Monitoring of Hearing Preservation during Cochlear Implantation. Life (Basel). 2022 Apr 25;12(5):636. doi: 10.3390/life12050636.
PubMed 35629304Verberne J, Risi F, Campbell L, Chambers S, O'Leary S. The Effect of Scala Tympani Morphology on Basilar Membrane Contact With a Straight Electrode Array: A Human Temporal Bone Study. Otol Neurotol. 2017 Jan;38(1):47-53. doi: 10.1097/MAO.0000000000001259.
PubMed 27755369
Study at a glance
From the registry record, last updated by the sponsor on 6 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Preservation of Hearing and Structure Using an Electrocochleography Based Corrective Action Guide
- ClinicalTrials.gov ID
- NCT06268340
- Acronym / sponsor ID
- PRESERVE / ABIntl-23-25
- Keywords
- Electrocochleography, Hearing Preservation, Structure Preservation, Intra-cochlear monitoring, Scalar translocations, Cochlear Microphonics, Corrective action guide, Cochlear Implants
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 102 participants (estimated)
- Lead sponsor
- Advanced Bionics AGIndustry (pharma, biotech, devices)
- Study start
- 15 May 2024 (actual)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 20 Feb 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention | Experimental | Procedure: ECochG monitored CI surgery incl. corrective action guideECochG monitored CI surgery incl. corrective action guide |
| Control | Active comparator | Procedure: Routine CI surgery without ECochG monitoringRoutine CI surgery without ECochG monitoring |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- 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
Key exclusion criteria (11 listed)
- Abnormal cochlear anatomy (including ossification) as identified by pre-operative radiological evaluation in the ear to be implanted
- Any pre-existing cochlear or middle ear pathology, such as otosclerosis, cholesteatoma, or previous middle ear surgery in the ear to be implanted
- 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
- Deafness due to lesions of the acoustic nerve or central auditory pathway
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ECochG monitored CI surgery incl. corrective action guideInterventional surgery with surgeon having access to intra-operative ECochG monitoring feedback to deploy ECochG based corrective action guide | Procedure or surgery | Intervention |
| Routine CI surgery without ECochG monitoringRoutine CI surgery with access to ECochG monitoring by surgeon | Procedure or surgery | Control |
Primary outcome
Hearing Preservation
Time frame: From pre-operative to 6 months post-operative
Difference in dB (absolute) and % (relative) in low-frequency hearing preservation measured via air conduction pure tone audiometry
2 secondary outcomes
Structure Preservation
Time frame: 1 month post-operative
Speech perception
Time frame: From pre-operative to 6 months post-operative
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Jan 2026.
- Background: PubMed 34600798Bester C, Collins A, Razmovski T, Weder S, Briggs RJ, Wei B, Zakaria AF, Gerard JM, Mitchell-Innes A, Tykocinski M, Kennedy R, Iseli C, Dahm M, Ellul S, O'Leary S. Electrocochleography triggered intervention successfully preserves residual hearing during cochlear implantation: Results of a randomised clinical trial. Hear Res. 2022 Dec;426:108353. doi: 10.1016/j.heares.2021.108353. Epub 2021 Sep 20.
- Background: PubMed 35452461Buechner A, Bardt M, Haumann S, Geissler G, Salcher R, Lenarz T. Clinical experiences with intraoperative electrocochleography in cochlear implant recipients and its potential to reduce insertion trauma and improve postoperative hearing preservation. PLoS One. 2022 Apr 22;17(4):e0266077. doi: 10.1371/journal.pone.0266077. eCollection 2022.
- Background: PubMed 21659922Carlson ML, Driscoll CL, Gifford RH, Service GJ, Tombers NM, Hughes-Borst BJ, Neff BA, Beatty CW. Implications of minimizing trauma during conventional cochlear implantation. Otol Neurotol. 2011 Aug;32(6):962-8. doi: 10.1097/MAO.0b013e3182204526.
- Background: PubMed 25839980Dalbert A, Sim JH, Gerig R, Pfiffner F, Roosli C, Huber A. Correlation of Electrophysiological Properties and Hearing Preservation in Cochlear Implant Patients. Otol Neurotol. 2015 Aug;36(7):1172-80. doi: 10.1097/MAO.0000000000000768.
- Background: PubMed 30113557Koka K, Riggs WJ, Dwyer R, Holder JT, Noble JH, Dawant BM, Ortmann A, Valenzuela CV, Mattingly JK, Harris MM, O'Connell BP, Litvak LM, Adunka OF, Buchman CA, Labadie RF. Intra-Cochlear Electrocochleography During Cochear Implant Electrode Insertion Is Predictive of Final Scalar Location. Otol Neurotol. 2018 Sep;39(8):e654-e659. doi: 10.1097/MAO.0000000000001906.
- Background: PubMed 30335669Giardina CK, Brown KD, Adunka OF, Buchman CA, Hutson KA, Pillsbury HC, Fitzpatrick DC. Intracochlear Electrocochleography: Response Patterns During Cochlear Implantation and Hearing Preservation. Ear Hear. 2019 Jul/Aug;40(4):833-848. doi: 10.1097/AUD.0000000000000659.
- Background: PubMed 23446225Gifford RH, Dorman MF, Skarzynski H, Lorens A, Polak M, Driscoll CL, Roland P, Buchman CA. Cochlear implantation with hearing preservation yields significant benefit for speech recognition in complex listening environments. Ear Hear. 2013 Jul-Aug;34(4):413-25. doi: 10.1097/AUD.0b013e31827e8163.
- Background: PubMed 30741914Lenarz T, Timm ME, Salcher R, Buchner A. Individual Hearing Preservation Cochlear Implantation Using the Concept of Partial Insertion. Otol Neurotol. 2019 Mar;40(3):e326-e335. doi: 10.1097/MAO.0000000000002127.
- Background: PubMed 36395515O'Leary S, Mylanus E, Venail F, Lenarz T, Birman C, Di Lella F, Roland JT Jr, Gantz B, Beynon A, Sicard M, Buechner A, Lai WK, Boccio C, Choudhury B, Tejani VD, Plant K, English R, Arts R, Bester C. Monitoring Cochlear Health With Intracochlear Electrocochleography During Cochlear Implantation: Findings From an International Clinical Investigation. Ear Hear. 2023 Mar-Apr 01;44(2):358-370. doi: 10.1097/AUD.0000000000001288. Epub 2022 Nov 8.
- Background: PubMed 31644474Saoji AA, Patel NS, Carlson ML, Neff BA, Koka K, Tarigoppula VSA, Driscoll CLW. Multi-frequency Electrocochleography Measurements can be Used to Monitor and Optimize Electrode Placement During Cochlear Implant Surgery. Otol Neurotol. 2019 Dec;40(10):1287-1291. doi: 10.1097/MAO.0000000000002406.
- Background: PubMed 35629304Skarzynski PH, Lorens A, Walkowiak A, Polak M, Skarzynski H. Multi-Frequency Intraoperative Monitoring of Hearing Preservation during Cochlear Implantation. Life (Basel). 2022 Apr 25;12(5):636. doi: 10.3390/life12050636.
- Background: PubMed 27755369Verberne J, Risi F, Campbell L, Chambers S, O'Leary S. The Effect of Scala Tympani Morphology on Basilar Membrane Contact With a Straight Electrode Array: A Human Temporal Bone Study. Otol Neurotol. 2017 Jan;38(1):47-53. doi: 10.1097/MAO.0000000000001259.
- Cochlear implants for children and adults with severe to profound deafness - Technology appraisal guidance \[TA566\]Link provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Matt E Smith, Dr principal investigator
Cambridge University Hospitals NHS Foundation Trust
7 sites in 7 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing ECochG monitored CI surgery incl. corrective action guide and Routine CI surgery without ECochG monitoring in people with Hearing Loss, Sensorineural and Severe-to-profound Hearing Loss, run by Advanced Bionics AG at 7 sites in 7 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 6 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 sites in Belgium, France, Germany, Italy, Poland and 2 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Unai Martinez de Estibariz, Mr (+34666964128, unai.martinez@advancedbionics.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Hearing Preservation (time frame: From pre-operative to 6 months post-operative). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06268340, which also lists 12 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Jan 2026.