Advanced Cochlear Implant Programming for Hearing Loss

(TFS4CIs Trial)

Overseen By Ray Goldsworthy, PhD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of Southern California

Disqualifiers: Younger than 18 years

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

24 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores new methods to program cochlear implants, aiming to enhance users' music perception and speech understanding. It focuses on delivering more detailed sound information to improve listening experiences. Two approaches are being tested: adjusting electrode placement (Electrode Location) and altering the stimulation rate (Stimulation Rate). Cochlear implant users aged 18 or older are encouraged to consider participating. As an unphased trial, this study offers participants the chance to contribute to innovative research that could significantly advance cochlear implant technology.

Do I need to stop my current medications for this trial?

The trial information does not specify whether you need to stop taking your current medications.

What prior data suggests that this cochlear implant programming technique is safe for users?

Research has shown that cochlear implants, which assist those with severe hearing loss, are generally safe. One study found that 94% of patients retained their hearing after using their implant for five years, indicating that these devices are effective and well-tolerated over time.

The Brazilian Society of Otology also confirms the safety of cochlear implants for individuals with severe hearing loss, noting their increasing use for various hearing issues.

Some studies are exploring whether altering the speed at which the implant sends signals to the brain can improve speech comprehension. Although specific safety data on this aspect is not clear, the implants themselves are considered safe.

Overall, cochlear implants have a strong safety record, which should reassure anyone considering participation in a study related to their use. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about this trial because it explores advanced techniques for cochlear implant programming, specifically focusing on electrode location and stimulation rate. Unlike traditional cochlear implant settings that are typically standardized, these techniques aim to customize the implant's function to the individual's unique auditory needs. By optimizing where the electrodes are placed and the rate at which they stimulate the auditory nerve, there is potential to significantly enhance sound quality and speech understanding for people with hearing loss. This personalized approach could lead to better hearing outcomes and a more natural listening experience compared to current one-size-fits-all programming methods.

What evidence suggests that this trial's treatments could be effective for improving music and speech perception in cochlear implant users?

This trial will compare different cochlear implant programming methods to improve hearing. Participants may receive adjustments to the stimulation rate, which research has shown can enhance speech understanding. One study found that older adults understood speech more clearly and reported improved quality of life when the signal rate was adjusted. Another group in this trial will have adjustments to the electrode location. Additionally, combining electrical and vibrational signals helped people understand speech in noisy environments. These findings suggest that various adjustments to cochlear implants could enhance how users hear music and speech. ^{1 4 6 7 8}

Are You a Good Fit for This Trial?

This trial is for cochlear implant users who want to improve their music and speech perception. It's not open to anyone under the age of 18.

Inclusion Criteria

You have a cochlear implant.

Exclusion Criteria

I am under 18 years old.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Baseline Assessment

Baseline electrode psychophysics prior to training to measure just-noticeable difference for pitch ranking based on stimulation cues

1 week

Training and Treatment

Participants undergo psychophysical training to improve pitch perception using cochlear implant stimulation cues

8 weeks

Weekly training sessions

Midpoint Assessment

Midpoint electrode psychophysics to measure progress in pitch discrimination

1 week

Follow-up

Participants are monitored for safety and effectiveness after training

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Electrode Location
• Stimulation Rate

Trial Overview The study tests how changing stimulation rates and electrode locations in cochlear implants affects the user's ability to perceive music and speech by including temporal fine structure information.

How Is the Trial Designed?

Group I: Stimulation Rate Experimental Treatment 2 Interventions

Group II: Electrode Location Active Control 2 Interventions

Who Is Running the Clinical Trial?

University of Southern California

Lead Sponsor

Trials

956

Recruited

1,609,000+

University of Rochester

Collaborator

Trials

883

Recruited

555,000+

Ohio State University

Collaborator

Trials

891

Recruited

2,659,000+

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC7190412/

The effect of stimulation rate on speech understanding in older ... The goal of this study was to determine if improvements in speech understanding were possible when CI users were programmed with non-default stimulation rates.

2. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/38420783/

Effect of reducing electrical stimulation rate on hearing ... Reducing the stimulation rate from 900 pps/ch to 500 pps/ch did not compromise the hearing outcomes evaluated in this study.

3. jamanetwork.com jamanetwork.com/journals/jamaotolaryngology/fullarticle/2769939

Hearing and Quality-of-Life Outcomes After Cochlear ... Older adults in this study achieved clinically meaningful improvement in both speech perception and patient-reported quality-of-life metrics ...

4. nature.com nature.com/articles/s41598-023-38468-0

Electro-vibrational stimulation results in improved speech ... We demonstrate a statistically significant and clinically relevant improvement for speech perception in noise of 1.9 dB signal-to-noise ratio.

5. pronews.cochlear.com pronews.cochlear.com/wp-content/uploads/2018/10/Roland_et_al-2018-Hybrid-long-term-data.pdf

Long‐term outcomes of cochlear implantation in patients ... Ninety-four percent of subjects had measurable hearing, and 72% continued to use electric-acoustic stimulation in the implanted ear after 5 years of implant use ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC6792393/

Long-Term Outcomes of Cochlear Implantation in Patients ... Measurable hearing was achieved and maintained in 94% of subjects after 5 years of implant use.

7. accessdata.fda.gov accessdata.fda.gov/cdrh_docs/pdf/P970051S205B.pdf

Summary of Safety and Effectiveness Data (SSED) The primary goal of the combined feasibility study + real-world data analysis was to gather pre- specified data points to demonstrate ...

8. sciencedirect.com sciencedirect.com/science/article/pii/S1808869424001277

Brazilian Society of Otology task force – cochlear implant ... CI is a safe device for auditory rehabilitation of patients with severe-to-profound hearing loss. In recent years, indications for unilateral hearing loss and ...