Cochlear Implant + Hearing Aid for Hearing Loss

Recruiting at 2 trial locations

Overseen By Jourdan T Holder, AuD, PhD

Age: Any Age

Sex: Any

Trial Phase: Academic

Sponsor: Hearts for Hearing

Disqualifiers: Autism, Auditory neuropathy, Neurological disorder, others

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

Approved in 2 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 7

160 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to explore how combining cochlear implants with hearing aids (Electric and Acoustic Stimulation, or EAS technology) can improve hearing abilities, especially in noisy environments. The study will focus on both adults and children with cochlear implants to better understand their speech and spatial hearing. Participants should have at least one cochlear implant and experience mild to severe hearing loss in both ears. This research will help audiologists refine treatment options for those with hearing loss. As an unphased trial, this study offers participants the chance to contribute to groundbreaking 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.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that Electric Acoustic Stimulation (EAS) technology is generally safe for people. One study found that adults using EAS experienced significant improvements in hearing and maintained good hearing over time. Another study confirmed that the MED-EL EAS System is a safe and effective choice for those with normal to moderate hearing loss in lower sound ranges. Although limited research exists on EAS in children, the positive results in adults suggest similar benefits might be expected for younger users. Overall, studies have shown that EAS technology is well-tolerated, with no major safety concerns reported. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about electric and acoustic stimulation (EAS) technology because it combines the benefits of cochlear implants and hearing aids in a novel way. While traditional treatments like hearing aids amplify sound and cochlear implants convert sound into electrical signals, EAS does both. This dual approach can enhance hearing for both children and adults by providing richer sound quality and improving speech recognition, especially in noisy environments. By tailoring the stimulation to the needs of the individual ear, EAS offers a more personalized and potentially more effective hearing solution.

What evidence suggests that this trial's treatments could be effective for hearing loss?

This trial will compare the use of Electric Acoustic Stimulation (EAS) technology in adults and children with cochlear implants. Research shows that adults using EAS technology can better understand speech in noisy environments and perform well in tasks involving sound localization. One study found that adults with high-frequency hearing loss benefit from EAS, with many maintaining good hearing over time. Another study confirmed that the MED-EL EAS System is safe and effective for adults with normal to moderate hearing loss in low frequencies.

For children, studies on EAS are also promising. Research is exploring how EAS can help children with some natural hearing improve their speech understanding. While the benefits are clearer in adults, early findings in children suggest potential for better hearing outcomes. ^{1 2 3 4 6}

Who Is on the Research Team?

René H Gifford, PhD

Principal Investigator

Hearts for Hearing

Are You a Good Fit for This Trial?

This trial is for children (5-17 years) and adults (18+ years) with hearing loss who can benefit from a cochlear implant combined with a hearing aid in the same ear. Participants must have some low-frequency hearing left, be willing to use EAS technology, and have typical cognitive abilities. Adults should not have single-sided deafness or any confounding diagnoses like autism or general cognitive impairment.

Inclusion Criteria

I am willing to use and track my hearing aid and cochlear implant usage.

I am over 18 and have normal hearing or use a cochlear implant with some natural hearing.

I have a cochlear implant and hearing loss in both ears.

Exclusion Criteria

My cognitive test score is below 26.

Your nonverbal intelligence score is less than 85.

You have a condition like autism, hearing nerve problems, a brain disorder, or difficulty thinking clearly that might affect the study results.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

EAS Activation and Initial Assessment

Participants undergo EAS activation and initial assessment of binaural cue sensitivity and speech recognition

1 month

1 visit (in-person)

Chronic EAS Use and Monitoring

Participants use EAS technology with periodic assessments of speech recognition and spatial discrimination

24 months

Regular visits at 6, 12, and 24 months

Follow-up

Participants are monitored for long-term outcomes and any adverse effects post-treatment

6 months

What Are the Treatments Tested in This Trial?

Interventions

• Electric and acoustic stimulation (EAS) technology

Trial Overview The study tests Electric Acoustic Stimulation (EAS), which combines a cochlear implant with a hearing aid in one ear, aiming to improve speech understanding and spatial hearing. It will compare the benefits of EAS in both children and adults against those using only standard cochlear implants.

How Is the Trial Designed?

Group I: Pediatric use of EAS Experimental Treatment 1 Intervention

Clinical intervention; Children with CI and the fitting of electric and acoustic stimulation (EAS) technology in the implanted ear(s).

Group II: Adult use of EAS Experimental Treatment 1 Intervention

Clinical intervention; Adults with CI and the fitting of electric and acoustic stimulation (EAS) technology in the implanted ear(s).

Group III: Children with Normal Hearing Active Control 1 Intervention

Children with normal hearing; acoustic only

Group IV: Adults with Normal Hearing Active Control 1 Intervention

Adult with normal hearing; acoustic only

Electric and acoustic stimulation (EAS) technology is already approved in European Union, United States for the following indications:

Approved in European Union as EAS for:

• Severe to profound sensorineural hearing loss in high frequencies with preserved low-frequency hearing

Approved in United States as EAS for:

• Severe to profound sensorineural hearing loss in high frequencies with preserved low-frequency hearing thresholds ranging from 0 to 60 dB at 125 to 500 Hz

Who Is Running the Clinical Trial?

Hearts for Hearing

Lead Sponsor

Trials

6

Recruited

200+

Vanderbilt University Medical Center

Lead Sponsor

Trials

922

Recruited

939,000+

National Institute on Deafness and Other Communication Disorders (NIDCD)

Collaborator

Trials

377

Recruited

190,000+

Published Research Related to This Trial

The EverProTM everolimus-eluting coronary stent system was found to be safe and effective in patients with coronary artery disease, with no major adverse cardiac events (MACE) or stent thrombosis reported during a 1-year follow-up of 77 patients.

The study demonstrated procedural success in all patients, indicating that the EverProTM stent can be a reliable option for treating coronary artery lesions, particularly in those with single-vessel disease.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Safety and performance of the EverProTM everolimus-eluting coronary stent system with biodegradable polymer in a real-world scenario. Trimukhe, R., Vani, P., Patel, A., et al.[2021]

In a study of 41 patients with acute coronary syndrome (ACS) and 59 patients with stable angina pectoris (SAP), everolimus-eluting stents (EESs) showed similar neointimal thickness between both groups after 9 months, indicating comparable healing responses.

The ACS group had a significantly lower rate of uncovered stent struts (11.5%) compared to the SAP group (12.5%), suggesting that EESs may provide favorable outcomes in ACS patients, although the clinical significance of these differences is small.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Vascular Healing Response after Everolimus-Eluting Stent Implantation in Acute Coronary Syndrome Culprit Lesions: Comparison with Implantation in Stable Angina Pectoris. Goryo, Y., Kume, T., Ueda, T., et al.[2022]

In a study involving 268 patients treated with the Amphilimus-eluting stent (AES) over 12 months, the incidence of major adverse cardiac events (MACE) was low at 4%, indicating the stent's clinical safety and efficacy in a high-risk population, particularly those with diabetes.

The most common complications leading to MACE were cardiovascular mortality (1.5%), myocardial infarction (2%), and target lesion revascularization (1.5%), with a stent thrombosis rate of 1.5%, suggesting that AES is a reliable option for patients undergoing percutaneous coronary intervention.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

12-Month clinical outcomes of amphilimus drug eluting stents in an all-comers South-East Asian registry. Ho, HH., Sinaga, DA., Arshad, MKM., et al.[2022]

In a study of 103 acute myocardial infarction patients, those treated with everolimus-eluting bioresorbable scaffolds (BRS) showed significantly better vessel healing compared to those with everolimus-eluting metallic stents (EES), particularly in ST-elevation myocardial infarction (STEMI) cases.

BRS demonstrated higher strut coverage (97.5% vs. 90.9%) and more frequent pre- and post-dilation procedures, indicating a more favorable healing response, while the mean neointimal thickness was similar between both groups.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Optical coherence tomography tissue coverage and characterization at six months after implantation of bioresorbable scaffolds versus conventional everolimus eluting stents in the ISAR-Absorb MI trial. Rai, H., Alfonso, F., Maeng, M., et al.[2022]

Electric-acoustic stimulation (EAS) effectively combines cochlear implants for high-frequency hearing with hearing aids for low-frequency sounds, benefiting patients who are profoundly deaf in high frequencies but retain some hearing in lower frequencies.

The success of EAS relies on preserving residual hearing, which is supported by innovations such as flexible electrode arrays and a unified audio processor, ensuring safe and effective treatment for patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

EAS-Combined electric and acoustic stimulation. Dhanasingh, A., Hochmair, I.[2021]

In a study involving 13 patients with severe to profound high- and mid-frequency hearing loss, combined electric and acoustic stimulation (EAS) significantly improved hearing outcomes, especially in noisy environments, with some patients experiencing up to a 72% increase in performance compared to using a cochlear implant alone.

EAS allowed for partial preservation of low-frequency hearing in 11 out of 13 patients, demonstrating its potential as an effective therapy for individuals with specific hearing loss profiles.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Combined electric and acoustic stimulation of the auditory system: results of a clinical study. Kiefer, J., Pok, M., Adunka, O., et al.[2022]

In a study of 383 patients treated with everolimus-eluting stents (EES) for in-stent restenosis (ISR), the 12-month target lesion failure rate was 10.9%, which is higher than the 4.9% rate observed in 4832 patients treated for non-ISR lesions, indicating a higher risk profile for ISR patients.

Despite the initial higher rates of complications in the ISR group, when matched with non-ISR patients, the differences in target lesion failure and other outcomes diminished, suggesting that EES is a safe and effective treatment for ISR over the long term.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Clinical outcomes in the percutaneous coronary intervention of in-stent restenosis with everolimus-eluting stents. Lee, MS., Yang, T., Mahmud, E., et al.[2015]

The study used a 3D-computational model to simulate the effects of cochlear implant electrodes on the basilar membrane (BM) stiffness, showing that this stiffening does not impact low-frequency hearing but can enhance perception of adjacent mid to high frequencies.

In a clinical evaluation of 13 subjects with residual hearing, a small but significant improvement in hearing thresholds was observed at 1.5 kHz, supporting the model's prediction that acoustic energy is focused around the fixed section of the BM, although caution is advised against amplifying high frequencies to prevent auditory discrimination issues.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Representation of acoustic signals in the human cochlea in presence of a cochlear implant electrode. Kiefer, J., Böhnke, F., Adunka, O., et al.[2006]

In a study involving 20 adults with normal hearing, both bimodal and electric acoustic stimulation (EAS) significantly improved consonant recognition, regardless of the specific configurations of hearing loss simulated.

EAS was found to transmit place information more effectively than bimodal hearing, indicating that the integration mechanisms for consonant information may be similar between the two hearing technologies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effects of the Configuration of Hearing Loss on Consonant Perception between Simulated Bimodal and Electric Acoustic Stimulation Hearing. Yoon, YS., Whitaker, G., Lee, YS.[2022]

Electric acoustic stimulation (EAS) effectively helps individuals with steeply sloping mid-to-high frequency hearing loss by preserving low-frequency hearing while providing significant benefits, especially in noisy environments.

Optimal fitting of both cochlear implants and hearing aids is crucial; reducing overlap in amplification between the two devices leads to better hearing outcomes, suggesting a tailored approach based on individual audiograms.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The influence of different speech processor and hearing aid settings on speech perception outcomes in electric acoustic stimulation patients. Vermeire, K., Anderson, I., Flynn, M., et al.[2007]

The MED-EL Electric-Acoustic Stimulation (EAS) System is shown to be a safe and effective treatment for adults with low-frequency hearing and severe-to-profound hearing loss in higher frequencies, with 92% of participants completing the study and 97% able to use the acoustic unit after 12 months.

At 12 months postactivation, 94% of subjects performed as well or better on speech perception tests in noise compared to their preoperative performance, indicating significant improvements in hearing capabilities with the EAS system.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Multicenter US Clinical Trial With an Electric-Acoustic Stimulation (EAS) System in Adults: Final Outcomes. Pillsbury, HC., Dillon, MT., Buchman, CA., et al.[2019]

Electroacoustic stimulation (EAS) is a promising new technology for patients with both low-frequency hearing and severe to profound high-frequency hearing loss, allowing for better auditory rehabilitation.

In a case report involving four patients, the surgical technique for EAS implantation was successful and uneventful, highlighting the importance of preserving low-frequency hearing during the procedure.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Electro acoustic stimulation of the auditory system: UNICAMP's surgical approach. Carvalho, GM., Valente, JP., Duarte, AS., et al.[2022]

Citations

1. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/39514431/

Hybrid Cochlear Implant Outcomes and Improving ... Patients with high-frequency hearing loss demonstrate significant long-term benefit with a hybrid CI including high rates of functional hearing preservation.

2. clinicaltrials.gov clinicaltrials.gov/study/NCT05923203

Combined Electric and Acoustic Hearing (EAS) in Children ... Many studies have shown that adult EAS users show significant benefits for speech understanding in noise and spatial hearing tasks.

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC6203459/

Electric and Acoustic Stimulation in Cochlear Implant ... Technical improvements have allowed preservation of low-frequency hearing in cochlear implant recipients, allowing for electric and acoustic stimulation in the ...

4. tandfonline.com tandfonline.com/doi/full/10.1080/00016489.2021.1888477

Full article: EAS-Combined electric and acoustic stimulation Electro-natural stimulation in partial deafness treatment of adult cochlear implant users: long-term hearing preservation results. ORL J Otorhinolaryngol ...

5. journals.lww.com journals.lww.com/otology-neurotology/fulltext/2018/03000/multicenter_us_clinical_trial_with_an.7.aspx

Multicenter US Clinical Trial With an Electric-Acoustic... The MED-EL EAS System is a safe and effective treatment option for adults with normal hearing to moderate sensorineural hearing loss in the low frequencies.

6. accessdata.fda.gov accessdata.fda.gov/cdrh_docs/pdf/p000025s084b.pdf

SUMMARY OF SAFETY AND EFFECTIVENESS DATA (SSED) The MED-EL EAS System provides an electric stimulation in the high frequency region of the cochlea and an acoustic stimulation via acoustic ...