Hearing and Structure Preservation Via ECochG

NCT06268340 | Recruiting

• 1 other identifier: ABIntl-23-25
• Study Type: interventional
• Target: 102
• Locations: 7 countries
• Sites: 7

Brief 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.

Conditions

Severe-to-profound Hearing Loss; Hearing Loss, Sensorineural

Keywords

Electrocochleography; Hearing Preservation; Structure Preservation; Intra-cochlear monitoring; Scalar translocations; Cochlear Microphonics; Corrective action guide; Cochlear Implants

Outcome Measures

Primary Outcomes (1)

• Hearing Preservation

  Difference in dB (absolute) and % (relative) in low-frequency hearing preservation measured via air conduction pure tone audiometry

  From pre-operative to 6 months post-operative

Secondary Outcomes (2)

• Structure Preservation

  1 month post-operative

• Speech perception

  From pre-operative to 6 months post-operative

Other Outcomes (1)

• Surgeons' feedback

  Through study completion, an average of 2.5 years

Study Arms (2)

Intervention

EXPERIMENTAL

ECochG monitored CI surgery incl. corrective action guide

Procedure: ECochG monitored CI surgery incl. corrective action guide

Control

ACTIVE COMPARATOR

Routine CI surgery without ECochG monitoring

Procedure: Routine CI surgery without ECochG monitoring

Interventions

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

Intervention

Routine CI surgery without ECochG monitoring PROCEDURE

Routine CI surgery with access to ECochG monitoring by surgeon

Control

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Aged 18 years of age or older
• 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

You may not qualify if:

• 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
• 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

Sponsors & Collaborators

• Advanced Bionics AG: lead

Study Sites (7)

Universitair Ziekenhuis Gent

Ghent, Gent, 9000, Belgium

RECRUITING

Le Centre Hospitalier Régional Universitaire de Tours

Tours, Tours, 37000, France

RECRUITING

Universitätsklinikum Freiburg Klinik

Freiburg im Breisgau, Freiburg, 79106, Germany

RECRUITING

Ospedale Martini

Torino, TO, 10141, Italy

RECRUITING

World Hearing Center

Warsaw, Nadarzyn, 05-830, Poland

RECRUITING

Hospital Universitario Clinico San Cecilio

Granada, Granada, 18007, Spain

RECRUITING

Cambridge University Hospitals NHS Foundation Trust

Cambridge, England, CB2 0QQ, United Kingdom

RECRUITING

Related Publications (12)

• 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.

  PMID: 34600798 BACKGROUND

• Buechner 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.

  PMID: 35452461 BACKGROUND

• Carlson 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.

  PMID: 21659922 BACKGROUND

• Dalbert 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.

  PMID: 25839980 BACKGROUND

• Koka 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.

  PMID: 30113557 BACKGROUND

• Giardina 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.

  PMID: 30335669 BACKGROUND

• Gifford 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.

  PMID: 23446225 BACKGROUND

• Lenarz 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.

  PMID: 30741914 BACKGROUND

• O'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.

  PMID: 36395515 BACKGROUND

• Saoji 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.

  PMID: 31644474 BACKGROUND

• Skarzynski 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.

  PMID: 35629304 BACKGROUND

• Verberne 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.

  PMID: 27755369 BACKGROUND

Related Links

• Cochlear implants for children and adults with severe to profound deafness - Technology appraisal guidance \[TA566\]

MeSH Terms

Conditions

Hearing Loss, Sensorineural

Condition Hierarchy (Ancestors)

Hearing Loss; Hearing Disorders; Ear Diseases; Otorhinolaryngologic Diseases; Sensation Disorders; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Matt E Smith, Dr

  Cambridge University Hospitals NHS Foundation Trust

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Unai Martinez de Estibariz, Mr

CONTACT

+34666964128; unai.martinez@advancedbionics.com

Martina Brendel, Ms

CONTACT

+4915222836491; martina.brendel@advancedbionics.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 30, 2024
• First Posted: February 20, 2024
• Study Start: May 15, 2024
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: January 6, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1); IT (1); BE (1); DE (1); GB (1); FR (1); PL (1)