Investigation to Evaluate the Safety and Effectiveness of Cochlear Implantation in Children and Adults With Unilateral Hearing Loss/Single-sided Deafness

Официальное название

A Post-approval, Prospective, Nonrandomized, Single-arm Multicenter Investigation to Evaluate the Safety and Effectiveness of Cochlear Implantation in Children and Adults With Unilateral Hearing Loss/Single-sided Deafness

Обзор

The aim of the study is to assess the continued efficacy and safety of cochlear implantation in participants aged 5 years and above with Unilateral Hearing Loss (UHL)/Single Sided Deafness (SSD) supporting a change indication for use.

Вмешательства

• Устройство The Cochlear™ Nucleus® Cochlear Implant (CI) System
  The Cochlear™ Nucleus® CI systems are designed to provide useful hearing. The system works by converting sound in the environment into electric pulses that stimulate the auditory nerve, allowing the brain to perceive sound. The Cochlear™ Nucleus® CI system has implanted and external components. Implanted component: The CI is surgically implanted under the skin behind the ear. It includes a receiver/stimulator to receive and decode the electrical signals from the sound processor and an electrod

Первичные конечные точки

• Change in sentence in noise scores at 12 months post-activation in the binaural (CI and normal hearing (NH)) listening condition compared to preoperatively in the best listening (NH alone or NH and hearing aid) condition in 3 speaker configurations. [Срок оценки: pre-implantation, 12 months post-activation]
• Number of procedure and device related adverse events classified by type, frequency and severity. [Срок оценки: 36 months post-activation]

Вторичные конечные точки (2)

• Change in participant reported spatial hearing at 12 months post-activation compared to pre-operative ratings. [Срок оценки: pre-implantation, 12 months post-activation]
• Change in word recognition at 12 months post-activation in the CI alone condition compared to preoperative aided condition in the poorer hearing ear alone. [Срок оценки: pre-implantation, 12 months post-activation]

Критерии участия

Критерии включения

• Individuals 18 years or older (Group A)

Ear to be Implanted:

Severe sensorineural hearing loss (HL) defined as: Pure-tone average at 0.5, 1, 2, 4 kHz >80 dB HL ; Aided Consonant-Nucleus-Consonant Test (CNC) score ≤5% and

Normal Hearing Ear:

Normal or near normal hearing defined as an average of (0.5, 1, 2, 4kHz) ≤ 30 dB HL

• Children 5 years to 17 years, 11 months (Group B)

Ear to be Implanted:

Severe sensorineural HL defined as: Pure-tone average at 0.5, 1, 2, 4 kHz >80 dB HL; Aided CNC score ≤5% and

Normal Hearing Ear:

Normal or near normal hearing defined as an average of (0.5, 1, 2, 4kHz) ≤ 30 dB HL

• Previous experience with a current conventional treatment option for unilateral \[SSD\] HL (HA, bone-conduction device, or CROS technology), if no previous experience a minimum trial period of two weeks is required
• English spoken as a primary language
• Willing and able to provide written informed consent

Критерии исключения

• Ossification, abnormal cochlear nerve or any other cochlear anomaly that might prevent complete insertion of the electrode array
• Previous cochlear implantation
• Hearing loss of neural or central origin, including auditory neuropathy
• Duration of profound sensorineural HL >10 years per self-report
• Active / chronic middle-ear infection; conductive HL in either ear
• Medical or psychological conditions that contraindicate undergoing surgery as determined by the Investigator
• Unrealistic expectations on the part of the participant/family, regarding the possible benefits, risks, and limitations that are inherent as determined by the Investigator
• Evidence of and/or suspected cognitive or developmental concern
• Unable or unwilling to comply with the requirements of the clinical investigation as determined by the Investigator
• Investigator site personnel directly affiliated with this study and/or their immediate families; immediate family is defined as a spouse, parent, child or sibling
• Cochlear employees or employees of Contract Research Organizations (CROs) or contractors engaged by Cochlear for the purposes of this investigation
• Pregnant or breastfeeding women
• Currently participating, or participated within the last 30 days, in another interventional clinical investigation/trial involving an investigational drug or device.

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 · 8 центров

• Stanford University — Palo Alto
• Rocky Mountain Ear Center — Englewood
• University of Iowa — Iowa City
• New York Eye and Ear Infirmary — New York
• University of North Carolina — Chapel Hill
• Nationwide Children's Hospital — Columbus
• University of Texas Southwestern Medical Center- Department of Otolaryngology Head and Nec — Dallas
• Virginia Mason Medical Center — Seattle

Идентификаторы

NCT: NCT05318417 · CAM5816

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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