Cochlear Implant for Hearing Loss

Phase-Based Estimates
1
Effectiveness
1
Safety
Fairview Health Services, Minneapolis, MN
Hearing Loss+5 More
Cochlear Implant - Device
Eligibility
< 18
All Sexes
Eligible conditions
Hearing Loss

Study Summary

This study is evaluating whether a cochlear implant may help children with hearing loss.

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Eligible Conditions

  • Hearing Loss
  • Deafness, Unilateral
  • Deafness
  • Asymmetric Hearing Loss
  • Single-Sided Deafness (SSD)
  • Unilateral Deafness
  • Hearing Loss, Unilateral

Treatment Effectiveness

Effectiveness Estimate

1 of 3

Study Objectives

This trial is evaluating whether Cochlear Implant will improve 4 primary outcomes and 8 secondary outcomes in patients with Hearing Loss. Measurement will happen over the course of Pre-Implant and 12 months post-implant.

12 months post-implant
Post-implant bimodal vs better ear alone soft speech understanding
15 months post-implant
Post-implant bimodal vs better ear alone sound localization
Post-implant bimodal vs better ear alone speech understanding in noise
Month 15
Change in pre-implant trajectory of Bimodal speech understanding in noise over time to post-implant trajectory over time
Month 12
Change in Poor ear alone word recognition in quiet from Pre-Implant to 12 months post-implant
Month 12
Change in Bimodal soft speech understanding from Pre-Implant to 12 months post-implant
Change in Poor ear alone audibility from Pre-Implant to 12 months post-implant
Month 15
Change in Bimodal sound localization from Pre-Implant to 15 months post-implant
Change in Bimodal speech understanding in noise from Pre-Implant to 15 months post-implant
Change in HEAR-QL ratings from Pre-Implant to 15 months post-implant
Change in PedsQL-MFS ratings from Pre-Implant to 15 months post-implant
Change in SSQ ratings from Pre-Implant to 15 months post-implant

Trial Safety

Safety Estimate

1 of 3

Trial Design

2 Treatment Groups

Control
AHL/SSD

This trial requires 80 total participants across 2 different treatment groups

This trial involves 2 different treatments. Cochlear Implant is the primary treatment being studied. Participants will all receive the same treatment. There is no placebo group. The treatments being tested are not being studied for commercial purposes.

AHL/SSD
Device
Children with asymmetric hearing loss or single-sided deafness
ControlNo treatment in the control group
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Cochlear Implant
2014
N/A
~20

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: 5 visits pre-implant over a minimum of 4 months and the 3, 6, 9, 12, and 15 month post-implant visits
This trial has the following approximate timeline: 3 weeks for initial screening, variable treatment timelines, and roughly 5 visits pre-implant over a minimum of 4 months and the 3, 6, 9, 12, and 15 month post-implant visits for reporting.

Closest Location

Fairview Health Services - Minneapolis, MN

Eligibility Criteria

This trial is for patients born any sex aged 18 and younger. There are 8 eligibility criteria to participate in this trial as listed below.

Mark “yes” if the following statements are true for you:
SSD: PTA at .5, 1, 2, 4 kHz ≤ 25 dB HL; CNC word score at 60 dB SPL ≥ 70%; Stable hearing for the past 6-mo period.
At least 4 ys of age and up to 14 yrs, 11 mos of age and able to complete all investigational procedures.
Parents and child fluent in English. Parents desire bilateral hearing for their child, are willing to comply with study requirements, including the pre-implant HA phase, and are able to provide informed consent.
Poor ear (AHL/SSD): PTA at .5, 1, 2 kHz > 70 dB HL; Aided CNC word recognition score at 60 dB SPL < 40%; SPHL duration ≥ 6 mos and ≤ 10 yrs at time of CI surgery; If > 5 yrs of age, evidence of non-congenital SPHL onset (e.g., passed newborn hearing screening); If ≤ 5 yrs of age, no restrictions on SPHL onset.
Better ear
AHL: PTA at .5, 1, 2, 4 kHz > 25 and ≤ 60 dB HL; Aided CNC word score at 60 dB SPL ≥ 55%; Currently using a HA; Stable hearing for the past 6-mo period. "Stable" is defined as thresholds that have not declined by more than 20 dB at three or more octave-interval audiometric frequencies.
Both ears of NH participants: PTA at .5, 1, 2, 4 kHz ≤ 25 dB HL.
To continue with cochlear implantation and into the CI phase of the study: Indication, via imaging, of a normal cochlear nerve and of cochlear anatomy in the ear to be implanted that allows full insertion of the electrode array. Imaging modality is at the discretion of the surgeon. In addition, better ear hearing must be stable throughout the HA phase.

Patient Q&A Section

Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

How many people get hearing loss a year in the United States?

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About 9.1 million US citizens will experience hearing loss within the next 10 yr. Approximately 80% of Americans are affected by hearing loss at some point in their lives.

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What are the signs of hearing loss?

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The signs of both bilateral and unilateral hearing loss include reduced ability to hear a person's own voice, background noise as well as other sounds in the environment, speech discrimination, difficulties understanding speech in background noise. summary: This article discusses the signs of hearing loss and presents the most common signs, including the following: difficulty in hearing familiar voice, noisy environment, reduced communication skills, difficulty making out words from speech and background noise. What are the signs of hearing loss? A hearing loss can be caused by a genetic disorder (congenital, also known as birth-related or inherited), old age, noise damage, or medication. A hearing loss may affect one or both ears.

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What is hearing loss?

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Hearing loss is a common condition, which is a direct result of aging. Hearing loss can be a serious problem in older adults. Hearing loss in the oldest age group, which often has the greatest hearing loss, can have enormous impact on quality of life. In addition, hearing loss will be an increasingly important issue for many middle-aged adults, and is not only a financial burden on employers but also can have an adverse impact on quality of life in people with hearing loss.

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Can hearing loss be cured?

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While hearing loss can be cured in some cases, hearing loss can never be completely cured. The underlying causes of hearing loss should be corrected to enable patients to hear even in listening chambers.

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What causes hearing loss?

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Many hearing disorders can be prevented by the use of the proper ear protection. Other causes of hearing loss that can be prevented include ear infections, noise from excessive loud instruments, and exposure to toxins such as noise.\n

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What are common treatments for hearing loss?

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The most common treatment for hearing loss is hearing aid"

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What is the primary cause of hearing loss?

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The study shows a high proportion of unknown causes (39%). There is a need to develop a better knowledge of the causes of hearing loss by performing more studies. The most frequent cause of an unknown disease is noise trauma (54%).

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Who should consider clinical trials for hearing loss?

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Clinical trial patients should be a special consideration as a target patient population. Hearing loss is a significant factor affecting patients' quality of life and functional performance, yet many patients may forgo treatments that would ameliorate their hearing loss without compromising their life.

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What is cochlear implant?

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The CI is an excellent way to protect hearing in many cases. Cochlear implantation is the most useful method of correcting hearing loss, because it provides an alternative to conventional hearing aid amplification and is therefore a preferred option whenever the patient meets the criteria for a cochlear implant. However, it may be necessary for some patients with severe hearing loss, bilateral cochlea damage, and/or brain damage who are unfit for normal sound transmission, to receive an intracochlear stimulus instead of a CI because it is not necessarily the best option.

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Is cochlear implant safe for people?

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Hearing loss after a cochlear implant can be treated safely with a cochlear implant and improves quality of life. The implant need not be extracted with or without a prior hearing surgery.

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How serious can hearing loss be?

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There can be two types of hearing loss, those that were caused by hearing loss and those that were congenital: either cochlear, vestibular, or auditory nerves may be affected; and are likely to be progressive. Hearing loss may be mild to very severe, and may present at any age. Patients should always have complete audiograms performed. Treatment should be directed towards correcting the hearing loss, and with proper interventions, often the hearing loss can be prevented.

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Have there been any new discoveries for treating hearing loss?

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The current management of hearing loss is focused on avoiding or reducing the loss of hearing and improving hearing handicap. Unfortunately, more researches were found that there is still a lack of effective treatment in some severe hearing loss conditions such as sudden sensorineural hearing loss or mixed hearing loss. We hope to learn more about the cause of hearing loss and develop more effective treatment that would prolong or restore hearing loss to a certain extent.

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