Clinical trial NCT05318417: Investigation to Evaluate the Safety and Effectiveness of Cochlear Implantation in Children and Adults With Unilateral Hearing Loss/Single-sided Deafness
Official title: 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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Hearing Loss, Unilateral
Deafness, Unilateral
Lead sponsor: Cochlear
Sponsor class: INDUSTRY
Collaborators: name: NAMSA
First posted: 2022-04-08
Enrollment: 60
Sex: ALL
Minimum age (years): 5
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: 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.


Eligibility criteria: Inclusion Criteria:

• 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

Exclusion Criteria:

* 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.

Primary outcomes:
measure: 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.
timeFrame: pre-implantation, 12 months post-activation
measure: Number of procedure and device related adverse events classified by type, frequency and severity.
timeFrame: 36 months post-activation
Secondary outcomes:
measure: Change in participant reported spatial hearing at 12 months post-activation compared to pre-operative ratings.
timeFrame: pre-implantation, 12 months post-activation
measure: 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.
timeFrame: pre-implantation, 12 months post-activation
Other outcomes:
Locations:
city: Palo Alto
country: United States
facility: Stanford University
state: California
city: Englewood
country: United States
facility: Rocky Mountain Ear Center
state: Colorado
city: Iowa City
country: United States
facility: University of Iowa
state: Iowa
city: New York
country: United States
facility: New York Eye and Ear Infirmary
state: New York
city: Chapel Hill
country: United States
facility: University of North Carolina
state: North Carolina
city: Columbus
country: United States
facility: Nationwide Children's Hospital
state: Ohio
city: Dallas
country: United States
facility: University of Texas Southwestern Medical Center- Department of Otolaryngology Head and Neck Surgery
state: Texas
city: Seattle
country: United States
facility: Virginia Mason Medical Center
state: Washington
Study officials:
affiliation: Cochlear
name: Jillian Crosson
role: STUDY_DIRECTOR
References: