Clinical Utility of Residual Hearing in the Cochlear Implant Ear

Hearing Loss Clinical Trial

Official title:

Clinical Utility of Residual Hearing in the Cochlear Implant Ear

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04707885
• Other study ID #: 2020H0477
• Secondary ID: U01DC018920-01
• Status: Recruiting
• Phase: N/A
• Start date: November 10, 2021
• Est. completion date: December 31, 2026

Study information

• Verified date: June 2023
• Source: Ohio State University
• Contact: Beth Miles-Markley
• Phone: 614-366-9244
• Email: beth.miles-markley[@]osumc.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The current study is a randomized multi-center clinical trial that investigates the role an intraoperative hearing monitoring system (electrocochleography) has on helping to save residual hearing in patients undergoing cochlear implantation (CI).

Description:

The clinical importance of residual acoustic hearing in CI remains unclear. It is estimated that only five percent of adult candidates undergo CI. A major barrier is the loss of residual hearing associated with surgery, meaning most patients lose any or all residual hearing as a result of the CI surgery, especially since the majority of today's candidates do not suffer from complete deafness. Hence, many candidates are faced with the decision to relinquish their remaining acoustic hearing in exchange for electric hearing via the CI, as CI surgery often results in complete loss of any residual hearing. However, recent developments in hearing monitoring systems during CI surgery have shown promise for providing the surgeon with live feedback of how the cochlear implant insertion process is proceeding, allowing the surgeon to make intraoperative adjustments during the insertion, potentially minimizing any trauma caused by the insertion of the implant, ultimately helping preserve residual hearing. This ultimately could lead to improvements in the rates of hearing preservation. Therefore, the current study seeks to investigate: 1) the advantage of using a hearing monitoring system (electrocochleography) monitoring guided CI surgery on hearing preservation rates, 2) determine the benefit that hearing aid/cochlear implant combined hearing provides participants over non-hearing preservation CI (electric-only stimulation from the CI) on measures of speech perception and quality of life.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 40
• Est. completion date: December 31, 2026
• Est. primary completion date: December 31, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 79 Years

Eligibility

Inclusion Criteria:

1. Provision of signed and dated informed consent form.

2. Adults, males and females, ages 18 -79 who have a bilateral sensorineural hearing loss with postlingual onset.

3. Minimum of 30 days experience with appropriately fit binaural amplification (standardized National Acoustic Laboratories (NAL) fitting method) verified with real ear measurements within 5 dB SPL of targets.

4. Limited benefit from conventional amplification in the best aided condition as defined

by test scores of:

1. The ear to implanted: Consonant-nucleus-consonant (CNC) words = 60% or AzBio sentences (+10, +5 dB SNR = 60% correct)

2. Contralateral ear: = 80% on CNC words or AzBio sentences (+10, +5 dB SNR = 80% correct)

5. Low frequency Pure Tone Average (PTA- 125, 250, 500 Hz) = 55 dB HL in the ear to be implanted.

6. Severe to profound mid to high-frequency sensorineural hearing loss (threshold average of 1000, 2000, 3000, and 4000 Hz =75 dB HL) in the ear to be implanted.

7. Low frequency PTA = 55 dB HL sloping to moderately severe to profound mid-to high frequency sensorineural hearing loss (threshold average of 1000, 2000, 3000, 4000 Hz = 60 dB) in the contralateral ear.

8. Proficient in English.

9. Undergoing implantation with a current generation CI device from either Cochlear Limited or Advanced Bionics AG.

1. Cochlear Limited devices include: Nucleus CI612, CI622, CI632, CI624

2. Advanced Bionics AG devices include: HiFocus SlimJ, Mid-Scala

10. Stated willingness and ability to complete testing and all associated study visits.

Exclusion Criteria:

1. Previous cochlear implantation.

2. Prelingual onset of hearing loss.

3. Abnormal inner ear anatomy on CT imaging.

4. Auditory neuropathy spectrum disorder.

5. Retrocochlear pathology such as a vestibular schwannoma or stroke.

6. Unwillingness or inability to comply with all investigational requirements including the randomization process.

7. Additional medical, or social barriers that would prevent completion of all study requirements.

8. Medical condition contraindicated for surgery.

9. Device selection of Med El CI (per the patient's selection).

Related Conditions & MeSH terms

• Deafness
• Hearing Loss
• Hearing Loss, Bilateral
• Hearing Loss, Sensorineural

Intervention

Device:
• Electrocochleography
The use of ECochG monitoring will be employed. This will be conducted intraoperatively during the entire portion of the CI electrode insertion component. For the purposes of this clinical trial, the stimulus will consist of a 500 Hz tone burst presented at ~105-110 dB SPL. This was chosen due to the time and resource limitations in the operating room. Hence, the surgical team can only utilize a very limited dataset for intraoperative decision making and previous studies have demonstrated that 500 Hz stimulation offers the most robust, reliable, and useful ECochG signal during electrode insertions.

Locations

Country	Name	City	State
United States	University of North Carolina, Chapel Hill	Chapel Hill	North Carolina
United States	Ohio State University Eye and Ear Institute	Columbus	Ohio
United States	University of Iowa	Iowa City	Iowa
United States	Medical College of Wisconsin	Milwaukee	Wisconsin
United States	Vanderbilt University	Nashville	Tennessee
United States	Mayo Clinic	Rochester	Minnesota
United States	Washington University in St. Louis	Saint Louis	Missouri

Sponsors (2)

Lead Sponsor	Collaborator
Ohio State University	National Institute on Deafness and Other Communication Disorders (NIDCD)

Country where clinical trial is conducted

United States, 

References & Publications (16)

Campbell L, Kaicer A, Sly D, Iseli C, Wei B, Briggs R, O'Leary S. Intraoperative Real-time Cochlear Response Telemetry Predicts Hearing Preservation in Cochlear Implantation. Otol Neurotol. 2016 Apr;37(4):332-8. doi: 10.1097/MAO.0000000000000972. — View Citation

Eggermont JJ. Ups and Downs in 75 Years of Electrocochleography. Front Syst Neurosci. 2017 Jan 24;11:2. doi: 10.3389/fnsys.2017.00002. eCollection 2017. — View Citation

Gantz BJ, Dunn C, Oleson J, Hansen M, Parkinson A, Turner C. Multicenter clinical trial of the Nucleus Hybrid S8 cochlear implant: Final outcomes. Laryngoscope. 2016 Apr;126(4):962-73. doi: 10.1002/lary.25572. Epub 2016 Jan 12. — View Citation

Gantz BJ, Hansen MR, Turner CW, Oleson JJ, Reiss LA, Parkinson AJ. Hybrid 10 clinical trial: preliminary results. Audiol Neurootol. 2009;14 Suppl 1(Suppl 1):32-8. doi: 10.1159/000206493. Epub 2009 Apr 22. — View Citation

Gautschi-Mills K, Khoza-Shangase K, Pillay D. Preservation of residual hearing after cochlear implant surgery: an exploration of residual hearing function in a group of recipients at cochlear implant units. Braz J Otorhinolaryngol. 2019 May-Jun;85(3):310-318. doi: 10.1016/j.bjorl.2018.02.006. Epub 2018 Mar 24. — View Citation

Gifford RH, Dorman MF, Shallop JK, Sydlowski SA. Evidence for the expansion of adult cochlear implant candidacy. Ear Hear. 2010 Apr;31(2):186-94. doi: 10.1097/AUD.0b013e3181c6b831. — View Citation

Gstoettner W, Helbig S, Settevendemie C, Baumann U, Wagenblast J, Arnoldner C. A new electrode for residual hearing preservation in cochlear implantation: first clinical results. Acta Otolaryngol. 2009 Apr;129(4):372-9. doi: 10.1080/00016480802552568. — View Citation

Gstoettner WK, Baumgartner WD, Franz P, Hamzavi J. Cochlear implant deep-insertion surgery. Laryngoscope. 1997 Apr;107(4):544-6. doi: 10.1097/00005537-199704000-00022. No abstract available. — View Citation

Harris MS, Riggs WJ, Giardina CK, O'Connell BP, Holder JT, Dwyer RT, Koka K, Labadie RF, Fitzpatrick DC, Adunka OF. Patterns Seen During Electrode Insertion Using Intracochlear Electrocochleography Obtained Directly Through a Cochlear Implant. Otol Neurotol. 2017 Dec;38(10):1415-1420. doi: 10.1097/MAO.0000000000001559. — View Citation

Hodges AV, Schloffman J, Balkany T. Conservation of residual hearing with cochlear implantation. Am J Otol. 1997 Mar;18(2):179-83. — View Citation

Koka K, Saoji AA, Litvak LM. Electrocochleography in Cochlear Implant Recipients With Residual Hearing: Comparison With Audiometric Thresholds. Ear Hear. 2017 May/Jun;38(3):e161-e167. doi: 10.1097/AUD.0000000000000385. — View Citation

Lan KK, DeMets DL. Changing frequency of interim analysis in sequential monitoring. Biometrics. 1989 Sep;45(3):1017-20. — View Citation

Pillsbury HC 3rd, Dillon MT, Buchman CA, Staecker H, Prentiss SM, Ruckenstein MJ, Bigelow DC, Telischi FF, Martinez DM, Runge CL, Friedland DR, Blevins NH, Larky JB, Alexiades G, Kaylie DM, Roland PS, Miyamoto RT, Backous DD, Warren FM, El-Kashlan HK, Slager HK, Reyes C, Racey AI, Adunka OF. Multicenter US Clinical Trial With an Electric-Acoustic Stimulation (EAS) System in Adults: Final Outcomes. Otol Neurotol. 2018 Mar;39(3):299-305. doi: 10.1097/MAO.0000000000001691. — 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

Scheperle RA, Tejani VD, Omtvedt JK, Brown CJ, Abbas PJ, Hansen MR, Gantz BJ, Oleson JJ, Ozanne MV. Delayed changes in auditory status in cochlear implant users with preserved acoustic hearing. Hear Res. 2017 Jul;350:45-57. doi: 10.1016/j.heares.2017.04.005. Epub 2017 Apr 12. — View Citation

Skinner MW, Holden TA, Whiting BR, Voie AH, Brunsden B, Neely JG, Saxon EA, Hullar TE, Finley CC. In vivo estimates of the position of advanced bionics electrode arrays in the human cochlea. Ann Otol Rhinol Laryngol Suppl. 2007 Apr;197:2-24. — View Citation

* Note: There are 16 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Preservation Advantage	Determine the hearing preservation advantage, by measuring low tone audiometry at the 3, 6,12 and 24 month timepoints, in hertz.	3, 6, 12, 24 months