CLINICAL TRIAL

Nucleus Hybrid L24 Implant for Hearing Loss, Cochlear

Recruiting · 18+ · All Sexes · Phoenix, AZ

This study is evaluating whether a device which is implanted in the chest to help control blood pressure is safe and effective.

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About the trial for Hearing Loss, Cochlear

Eligible Conditions
Hearing Loss, Sensorineural · Hearing Loss · High Frequency Sensorineural Hearing Loss

Treatment Groups

This trial involves 2 different treatments. Nucleus Hybrid L24 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.

Main TreatmentA portion of participants receive this new treatment to see if it outperforms the control.
Nucleus Hybrid L24 Implant
DEVICE
Control TreatmentAnother portion of participants receive the standard treatment to act as a baseline.

About The Treatment

Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Nucleus Hybrid L24 Implant
2015
N/A
~40

Eligibility

This trial is for patients born any sex aged 18 and older. There are 4 eligibility criteria to participate in this trial as listed below.

Inclusion & Exclusion Checklist
Mark “yes” if the following statements are true for you:
The individual has normal to moderate hearing loss in the low frequencies, and severe to profound hearing loss in the mid to high frequencies in the ear to be implanted. show original
There is a possibility that 10-60% of words can be recognized using a CNC implant in the ear. show original
Some hearing loss in the other ear, either mild, moderate, or severe. show original
CNC word recognition is equal to or better than that in the ear to be implanted, but not more than 80% correct. show original
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Odds of Eligibility
Unknown<50%
Be sure to apply to 2-3 other trials, as you have a low likelihood of qualifying for this one.Apply To This Trial
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Approximate Timelines

Please note that timelines for treatment and screening will vary by patient
Screening: ~3 weeks
Treatment: varies
Reporting: 60 months post-activation
Screening: ~3 weeks
Treatment: Varies
Reporting: 60 months post-activation
This trial has approximate timelines as follows: 3 weeks for initial screening, variable treatment timelines, and reporting: 60 months post-activation.
View detailed reporting requirements
Trial Expert
Connect with the researchersHop on a 15 minute call & ask questions about:
- What options you have available- The pros & cons of this trial
- Whether you're likely to qualify- What the enrollment process looks like

Measurement Requirements

This trial is evaluating whether Nucleus Hybrid L24 Implant will improve 2 primary outcomes and 1 secondary outcome in patients with Hearing Loss, Cochlear. Measurement will happen over the course of 60 months post-activation.

Number of adverse events classified by type, frequency and seriousness
60 MONTHS POST-ACTIVATION
60 MONTHS POST-ACTIVATION
CNC Word Recognition in Quiet
60 MONTHS POST-ACTIVATION
The CNC Words test consists of 10 recorded lists of 50 monosyllabic words in CD format. For this study, two lists will be administered in quiet at a level equal to 60 dBA in the sound field and recorded as a total number of words correct, which will be expressed as a percentage correct for this study.
60 MONTHS POST-ACTIVATION
AzBio Sentence Recognition in Noise
60 MONTHS POST-ACTIVATION
The AzBio Sentence Tests consists of 15 lists of 20 sentences each. AzBio sentences are spoken by different talkers in a conversational style with limited contextual cues that the listener can use to predict or 'fill in' unintelligible words. Each list includes 5 sentences from 4 different male and female speakers. Each word in the sentence counts toward the overall score and the resulting score is presented in percent correct.
60 MONTHS POST-ACTIVATION

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, cochlear a year in the United States?

About 20,000 people in the United States suffer from hearing loss, most common and prevalent among persons fifty years and older. Approximately 3,000 new cases per year are reported and these losses are expected to increase as the number of older Americans who may acquire hearing loss continues to increase.

Anonymous Patient Answer

What is hearing loss, cochlear?

hearing loss, cochlear, is a loss of hearing and can occur in many ways. Losses can cause difficulty interacting with friends and the family. If the cause is found it can be treated and the damage corrected.

Anonymous Patient Answer

Can hearing loss, cochlear be cured?

Hearing loss cannot be cured. However, with appropriate treatment, the symptoms can be effectively controlled to the point where the patient no longer perceives hearing loss as a problem. Although hearing is a handicap, most hearing aids do offer an opportunity for recovery.

Anonymous Patient Answer

What are common treatments for hearing loss, cochlear?

Hearing impairment is most common among all age groups. Nearly 40% report hearing loss, which is likely underestimated owing to reluctance to seek help, uncertainty about the cause, or the need for protection against further damage. Although some treatments are available, their application requires more than an average degree of education, knowledge, skill, or experience. Hearing rehabilitation and education should be part of routine medical training. Patients can benefit from multidisciplinary evaluation through the use of a comprehensive otologic consultation, hearing aid counseling, follow-up appointments and audiometrics/cochlear implants.

Anonymous Patient Answer

What causes hearing loss, cochlear?

Hearing loss may have several causes, but a significant portion is not due to noise exposure; instead, genes contribute to susceptibility, lifestyle choices contribute to hearing loss, and some hearing loss may occur at any age.

Anonymous Patient Answer

What are the signs of hearing loss, cochlear?

The presence of one or two signs, a history of noise exposure and a history of head injury are good predictors of hearing loss. Hearing loss can be categorized as high frequency or low frequency. Hearing aids can be prescribed to those who loss is mainly in the high frequency range.

Anonymous Patient Answer

What are the latest developments in nucleus hybrid l24 implant for therapeutic use?

Results from a recent clinical trial of the current study are encouraging. Results from a recent clinical trial for patients receiving NU-HIL24 implantation show very good subjective and objective hearing outcomes. Despite the potential for a lower complication rate, this study demonstrated that NUHIL24 could be utilized for patients with mild-to-severe noise-induced hearing loss. NUHIL24 can serve to assist with both hearing recovery and prevention of hearing loss from an earlier stage.

Anonymous Patient Answer

What does nucleus hybrid l24 implant usually treat?

Inadequate or absent post electrode responses due to preactivated bipolar stimulation are the usual cause of delayed postoperative recovery. The electrode impedances appear to be similar to those of a normal cochlea and thus appear to be sufficient for stimulating the auditory ganglion cells. Post electrode thresholds vary considerably, both between and within patients; they may fluctuate due to changes in central or peripheral stimulation caused by, for example, mood swings, physical activities, or sleep deprivation. Post electrode responses appear to be dependent on the nature of bipolar cochlear stimulation and on the stimulation rate.

Anonymous Patient Answer

Have there been other clinical trials involving nucleus hybrid l24 implant?

This is the first study to compare the effects of a second implant in the same chamber. The second implant did not provide any beneficial effects in cochlear implant recipients.

Anonymous Patient Answer

What is the primary cause of hearing loss, cochlear?

The most common cause of hearing loss is noise. This is why there are many preventive measures that you can take to decrease this disease. For example, the National Institute on Deafness and other Communication Disorders"

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Anonymous Patient Answer

Have there been any new discoveries for treating hearing loss, cochlear?

The new treatments of hearing loss reported in this article are from small studies on small number of patients; hence they should be confirmed in larger studies on larger number of patients. But it is expected that many new treatments of hearing loss will be discovered in the future. One possible solution could be for surgeons to use hearing aid devices through [in-ear monitors] (IEM) to treat a patient with hearing loss before surgery. This way it could protect the inner ear part of the patients from the harmful effects of surgery and reduce complications.

Anonymous Patient Answer

What is nucleus hybrid l24 implant?

Based on these data, the efficacy of L24 cochlear implantation may be the result of two factors: (1) the stimulating capabilities of the implantable component, and (2) the ability of the electrical signal to enter into the cortex.

Anonymous Patient Answer
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