Single-Sided Deafness and Asymmetric Hearing Loss

Официальное название

Single-Sided Deafness and Asymmetric Hearing Loss Post-Approval Study

Обзор

The purpose of the study is to evaluate the long-term safety and effectiveness of cochlear implantation of the approved population in adults and children with single-sided deafness and asymmetric hearing loss.

Подробное описание

The study will be conducted as a single-subject, repeated measures, multi center study at 6 sites. Sixty-five subjects will be enrolled in this study. Six centers across the United States and Canada will recruit subjects into this study. Study subjects will be followed for a minimum of 3 years post-implantation of the device.

Вмешательства

• Устройство MED-EL Cochlear Implant System
  Cochlear implant and audio processor

Первичные конечные точки

• Long-term performance of the Cochlear Implant System will be assessed through speech perception testing in noise completed through three years (36 months) post implantation [Срок оценки: Three years (36 months) post implantation]

Вторичные конечные точки (4)

• Long term performance of the Cochlear Implant System will be summarized through speech perception testing in noise completed through three years (36 months) post implantation [Срок оценки: Three years (36 months) post implantation]
• Long term performance of the Cochlear Implant System will be assessed through speech perception testing in quiet completed through three (36 months) post implantation [Срок оценки: Three years (36 months) post implantation]
• Long term subjective benefit of the Cochlear Implant System will be assessed through three years (36 months) post implantation [Срок оценки: Three years (36 months) post implantation]
• Long term safety will be evaluated for all study subjects through three (36 months) years post implantation [Срок оценки: Three years (36 months) post implantation]

Критерии участия

Критерии включения

• Five years of age or older at the time of implantation
• Unilateral profound hearing loss, as defined by a pure-tone average (500, 1000, 2000, and 4000 Hz) of 90 dB or greater in the ear to be implanted
• Sensorineural hearing loss in the ear to be implanted, as defined by an air-bone gap less than or equal to 10 dB at two or more frequencies out of 500, 1000, 2000, and 4000 Hz and a diagnosed pathology of the outer or middle ear
• Normal hearing or mild to moderate hearing loss in the non-implanted ear, as defined by a pure-tone average (500, 1000, 2000, and 4000 Hz) of 55 dB or less
• Word recognition in the ear to be implanted of 5% or less on CNC word score in quiet
• Previous experience with an appropriately-fit Contralateral Routing of Signal (CROS) hearing aid, BI-Contralateral Routing of Signal (CROS) hearing aid, bone conduction, or traditional hearing aid, as deemed appropriate by investigator
• Fluent in English

Критерии исключения

• Duration of profound hearing loss of 10 years or more
• Absence of cochlear development or non-functionality of cochlear nerve
• Other retrocochlear hearing loss
• Evidence of severe cochlear malformation (i.e., common cavity or ossification)
• External or middle ear infection
• Suspected developmental or cognitive concern
• Other medical contraindication for surgery or anesthesia

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

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Не применимо

Модель

Одна группа

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

США · 5 центров

• Ann & Robert H. Lurie Children's Hospital of Chicago — Chicago
• University of Iowa — Iowa City
• New York Eye and Ear Infirmary — New York
• University of North Carolina — Chapel Hill
• Virginia Mason Medical Center — Seattle

Канада · 1 центр

• Sunnybrook Health Sciences Center — Toronto

Публикации

• Arndt S, Laszig R, Aschendorff A, Hassepass F, Beck R, Wesarg T. Cochlear implant treatment of patients with single-sided deafness or asymmetric hearing loss. HNO. 2017 Aug;65(Suppl 2):98-108. doi: 10.1007/s00106-016-0297-5. PMID 28188428
• Arndt S, Prosse S, Laszig R, Wesarg T, Aschendorff A, Hassepass F. Cochlear implantation in children with single-sided deafness: does aetiology and duration of deafness matter? Audiol Neurootol. 2015;20 Suppl 1:21-30. doi: 10.1159/000380744. Epub 2015 May 19. PMID 25999052
• Buss E, Dillon MT, Rooth MA, King ER, Deres EJ, Buchman CA, Pillsbury HC, Brown KD. Effects of Cochlear Implantation on Binaural Hearing in Adults With Unilateral Hearing Loss. Trends Hear. 2018 Jan-Dec;22:2331216518771173. doi: 10.1177/2331216518771173. PMID 29732951
• Dillon MT, Buss E, Rooth MA, King ER, Deres EJ, Buchman CA, Pillsbury HC, Brown KD. Effect of Cochlear Implantation on Quality of Life in Adults with Unilateral Hearing Loss. Audiol Neurootol. 2017;22(4-5):259-271. doi: 10.1159/000484079. Epub 2018 Jan 4. PMID 29298446
• Niparko JK, Cox KM, Lustig LR. Comparison of the bone anchored hearing aid implantable hearing device with contralateral routing of offside signal amplification in the rehabilitation of unilateral deafness. Otol Neurotol. 2003 Jan;24(1):73-8. doi: 10.1097/00129492-200301000-00015. PMID 12544032
• Van de Heyning P, Vermeire K, Diebl M, Nopp P, Anderson I, De Ridder D. Incapacitating unilateral tinnitus in single-sided deafness treated by cochlear implantation. Ann Otol Rhinol Laryngol. 2008 Sep;117(9):645-52. doi: 10.1177/000348940811700903. PMID 18834065
• Vermeire K, Van de Heyning P. Binaural hearing after cochlear implantation in subjects with unilateral sensorineural deafness and tinnitus. Audiol Neurootol. 2009;14(3):163-71. doi: 10.1159/000171478. Epub 2008 Nov 13. PMID 19005250

Идентификаторы

NCT: NCT04506853 · P000025/S113

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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