Clinical Utility of Residual Hearing in the Cochlear Implant Ear

Обзор

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).

Подробное описание

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.

Вмешательства

• Устройство 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

Первичные конечные точки

• Preservation Advantage [Срок оценки: 3, 6, 12, 24 months]

Критерии участия

Критерии включения

• Provision of signed and dated informed consent form.
• Adults, males and females, ages 18 -79 who have a bilateral sensorineural hearing loss with postlingual onset.
• 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.
• Limited benefit from conventional amplification in the best aided condition as defined by test scores of:

• The ear to implanted: Consonant-nucleus-consonant (CNC) words ≤ 60% or AzBio sentences (+10, +5 dB SNR ≤ 60% correct)
• Contralateral ear: ≤ 80% on CNC words or AzBio sentences (+10, +5 dB SNR ≤ 80% correct)
• Low frequency Pure Tone Average (PTA- 125, 250, 500 Hz) ≤ 55 dB HL in the ear to be implanted.
• 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.
• 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.
• Proficient in English.
• Undergoing implantation with a current generation CI device from either Cochlear Limited or Advanced Bionics AG.

• Cochlear Limited devices include: Nucleus CI612, CI622, CI632, CI624
• Advanced Bionics AG devices include: HiFocus SlimJ, Mid-Scala
• Stated willingness and ability to complete testing and all associated study visits.

Критерии исключения

• Previous cochlear implantation.
• Prelingual onset of hearing loss.
• Abnormal inner ear anatomy on CT imaging.
• Auditory neuropathy spectrum disorder.
• Retrocochlear pathology such as a vestibular schwannoma or stroke.
• Unwillingness or inability to comply with all investigational requirements including the randomization process.
• Additional medical, or social barriers that would prevent completion of all study requirements.
• Medical condition contraindicated for surgery.
• Device selection of Med El CI (per the patient's selection).

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

США · 5 центров

• Mayo Clinic — Rochester
• Washington University in St. Louis — St Louis
• University of North Carolina, Chapel Hill — Chapel Hill
• Ohio State University Eye and Ear Institute — Columbus
• Medical College of Wisconsin — Milwaukee

Публикации

• 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. PMID 28174524
• 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. PMID 26756395
• 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. PMID 19390173
• 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. PMID 29631897
• 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. PMID 20071994
• 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. PMID 9111389
• 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. PMID 19140036
• 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. PMID 26859542

Идентификаторы

NCT: NCT04707885 · 2020H0477 · U01DC018920-01

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗