CI632 Hearing Aid for Low-Frequency Hearing Loss

No longer recruiting at 4 trial locations

Overseen By Michael Hoa, MD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Cochlear

Disqualifiers: Age over 70, Cochlear anomaly, others

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

Compensation: Varies

Number of Visits: Unknown

Duration: 12 months

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores the effectiveness of the CI632 Slim Modiolar Electrode for individuals with low-frequency hearing loss. Researchers aim to determine if this device can improve hearing and speech understanding for those who retain some low-frequency hearing but struggle with higher frequencies. This study suits adults who have experienced low-frequency hearing issues for some time, can still hear some low sounds, but have difficulty with higher ones. Participants should be comfortable communicating in English and willing to sign a consent form. As an unphased trial, this study offers participants the chance to contribute to innovative research that could enhance hearing solutions for many.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinator or your doctor.

What prior data suggests that the CI632 Slim Modiolar Electrode is safe for adults with low-frequency hearing loss?

Research has shown that the CI632 Slim Modiolar Electrode is generally well-accepted by patients. In one study, 25% of participants retained their full hearing, while 60% retained some hearing, indicating that many experience only minor hearing loss after the procedure. Another study found that 20% of patients maintained their hearing one year after receiving the implant. These results provide some reassurance about the safety of the CI632. However, individual experiences can vary. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the CI632 Slim Modiolar Electrode because it offers a more precise and less invasive option for treating low-frequency hearing loss compared to traditional hearing aids. Unlike standard hearing aids that amplify sound broadly, the CI632 electrode is designed to be placed closer to the auditory nerve, which can improve sound clarity and reduce background noise. This targeted approach provides patients with a more natural listening experience and could lead to better overall hearing outcomes. Additionally, its slim design allows for easier insertion and potentially quicker recovery times.

What evidence suggests that the CI632 Slim Modiolar Electrode is effective for low-frequency hearing loss?

Research has shown that the CI632 Slim Modiolar Electrode, under study in this trial, might aid in addressing low-frequency hearing loss. Its design positions it close to the hearing nerve, potentially preserving hearing and enhancing sound clarity. One study found that patients experienced only a small change in low-frequency hearing, with an average loss of just -13.9 dB. Additionally, the Slim Modiolar Electrode demonstrated better outcomes than other electrodes, such as lateral wall electrodes, by preserving the ear's natural structure. These findings suggest that the CI632 could be a promising option for individuals with low-frequency hearing loss. ^{1 6 7 8 9}

Are You a Good Fit for This Trial?

Adults aged 18+ with low-frequency hearing loss who speak English and can consent. They must have a specific range of hearing loss in both ears, as measured by certain tests, and not exceed a word recognition score. Excluded are those over 70, with long-term or early-onset severe hearing loss, other ear problems, medical/psychological surgery risks, unrealistic expectations about the device's benefits/risks, additional handicaps affecting test participation, current involvement in another trial with drugs/devices or cochlear anomalies.

Inclusion Criteria

Your hearing loss in the ear to be implanted is too severe for this study.

Your hearing in the other ear is worse than a certain level when tested at specific frequencies.

Willing and able to provide written informed consent

Exclusion Criteria

You work for Cochlear or a company that helps Cochlear with this study.

I have been diagnosed with Auditory Neuropathy.

Currently participating, or has participated in the last 30 days, in another interventional clinical investigation/trial involving an investigational drug or device

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive the CI632 implant and undergo audiometry and speech perception testing

12 months

Follow-up

Participants are monitored for safety and effectiveness after treatment

2 months

What Are the Treatments Tested in This Trial?

Interventions

• CI632 Slim Modiolar Electrode

Trial Overview The study is testing the CI632 Slim Modiolar Electrode's performance on adults with residual low-frequency hearing. It aims to assess how well participants can hear (audiometry) and understand speech (speech perception) after implantation. The trial will include only 15 participants meeting strict criteria for their level of hearing impairment.

How Is the Trial Designed?

Group I: CI632 Slim Modiolar Electrode Experimental Treatment 1 Intervention

Who Is Running the Clinical Trial?

Cochlear

Lead Sponsor

Trials

96

Recruited

6,300+

Headquarters

Sydney, Australia

Dig Howitt

Cochlear

Chief Executive Officer since 2018

BE (Hons), MBA

Michael del Prado

Cochlear

Chief Medical Officer since 2022

MD, MSc, FRACP, FAAHMS, FAICD

Citations

1. sciencedirect.com sciencedirect.com/science/article/abs/pii/S0196070922000096

Natural course of residual hearing preservation with a slim ... We compared the effect of a slim modiolar electrode (SME) and a slim straight electrode (SSE), implanted by a single surgeon, on progression of residual hearing ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12321687/

Cochlear implantation with Slim Modiolar Electrode ... In the long term, the results of this study showed a low frequency hearing loss of − 13.9 dB compared to previous thresholds. Across all ...

3. cochlear.com cochlear.com/at/de/campaign/inspired-by-a-lifetime-of-hearing-performance

Inspired by a lifetime of hearing performance In research studies, the Slim Modiolar electrode delivered better outcomes on average than a lateral wall electrode.8,9. Protecting the natural structure of ...

4. withpower.com withpower.com/trial/ci632-hearing-aid-for-low-frequency-hearing-loss-f568a

CI632 Hearing Aid for Low-Frequency Hearing Loss The CI632 Slim Modiolar Electrode is unique because it is designed to be placed close to the auditory nerve, which may help preserve hearing and improve sound ...

5. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11938487/

The Effect of Cochlear Implant Electrode Array Type on ... Evidence indicates that lateral wall (LW) electrodes can improve hearing preservation when compared to perimodiolar (PM) electrodes.

6. link.springer.com link.springer.com/article/10.1007/s00405-025-09267-2

Cochlear implantation with Slim Modiolar Electrode ... Complete postoperative hearing preservation was achieved in 25% (n = 52) of the study group, while partial preservation was observed in 60% of ...

7. cdn.clinicaltrials.gov cdn.clinicaltrials.gov/large-docs/42/NCT04750642/Prot_001.pdf

NCT04750642 Approval date: 07 Nov 2022 The intended purpose of the CI632D IMD is the restoration of hearing function in an adult population with post-lingual, bilateral, moderate to profound ...

8. uhhospitals.org uhhospitals.org/for-clinicians/articles-and-news/articles/2022/11/novel-cochlear-implant-trials-underway-at-university-hospitals

Novel Cochlear Implant Trials Underway at University ... “The advancement has the potential to benefit all cochlear implant patients because reducing inflammation improves overall outcomes, even on ...

9. researchgate.net researchgate.net/publication/339985643_Immediate_and_1-Year_Outcomes_with_a_Slim_Modiolar_Cochlear_Implant_Electrode_Array

Immediate and 1-Year Outcomes with a Slim Modiolar ... Sixty-one patients were identified with preservable hearing (low-frequency pure tone average ≤80 dB), and 12 of 61 (20%) preserved hearing at 1 year. Conclusion ...