Hearing and Structure Preservation Via ECochG

Hearing Loss, Sensorineural Clinical Trial

— PRESERVE  

Official title:

Preservation of Hearing and Structure Using an Electrocochleography Based Corrective Action Guide

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06268340
• Other study ID #: ABIntl-23-25
• Status: Not yet recruiting
• Phase: N/A
• Start date: February 29, 2024
• Est. completion date: June 30, 2026

Study information

• Verified date: February 2024
• Source: Advanced Bionics AG
• Contact: Unai Martinez de Estibariz, Mr
• Phone: +34666964128
• Email: unai.martinez[@]advancedbionics.com
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 102
• Est. completion date: June 30, 2026
• Est. primary completion date: June 30, 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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

Related Conditions & MeSH terms

• Deafness
• Hearing Loss
• Hearing Loss, Sensorineural
• Severe-to-profound Hearing Loss

Intervention

Procedure:
• ECochG monitored CI surgery incl. corrective action guide
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
Routine CI surgery with access to ECochG monitoring by surgeon

Locations

Country	Name	City	State
Belgium	Universitair Ziekenhuis Gent	Gent
France	Le Centre Hospitalier Régional Universitaire de Tours	Tours
Germany	Universitätsklinikum Freiburg Klinik	Freiburg
Italy	Ospedale Martini	Torino	TO
Poland	World Hearing Center	Warsaw	Nadarzyn
United Kingdom	Cambridge University Hospitals NHS Foundation Trust	Cambridge	England

Sponsors (1)

Lead Sponsor	Collaborator
Advanced Bionics AG

Countries where clinical trial is conducted

Belgium,  France,  Germany,  Italy,  Poland,  United Kingdom, 

References & 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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. Erratum In: Otol Neurotol. 2017 Jan;38(1):159. — View Citation

* Note: There are 12 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Surgeons' feedback	Qualitative feedback on surgical experience measured via a questionnaire	Through study completion, an average of 2.5 years
Primary	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	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	1 month post-operative
Secondary	Speech perception	Difference in speech perception scores in both quiet (%) and noise (dB SNR) using the International Matrix Test	From pre-operative to 6 months post-operative

External Links

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