Cochlear Implant + Hearing Aid for Hearing Loss

Recruiting at 2 trial locations

Overseen By Jonathan Neukam, AuD

Age: Any Age

Sex: Any

Trial Phase: Academic

Sponsor: Vanderbilt University Medical Center

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

Trial Summary

Will I have to stop taking my current medications?

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

What data supports the effectiveness of the treatment Electric and Acoustic Stimulation (EAS) technology for hearing loss?

Research shows that combining a cochlear implant with a hearing aid (EAS) can significantly improve hearing, especially in noisy environments, for people with severe high-frequency hearing loss but some low-frequency hearing. In one study, 7 out of 13 patients heard better in noisy settings with EAS compared to using a cochlear implant alone, with improvements up to 72%. ^{1 2 3 4 5}

Is the cochlear implant and hearing aid combination generally safe for humans?

The cochlear implant and hearing aid combination, known as Electric-Acoustic Stimulation (EAS), has been studied for safety in humans. Research shows that hearing can be partially preserved in most patients, and necessary safety studies were conducted before its use in humans. However, the introduction of a cochlear implant electrode may affect the inner ear's properties, which is an important consideration for safety. ^{1 2 3 6 7}

How does the Cochlear Implant + Hearing Aid treatment differ from other treatments for hearing loss?

The Cochlear Implant + Hearing Aid treatment, known as Electric and Acoustic Stimulation (EAS), is unique because it combines electrical stimulation from a cochlear implant with acoustic amplification from a hearing aid. This dual approach allows individuals with partial hearing loss to benefit from both technologies, enhancing their ability to hear a wider range of sounds compared to using either device alone. ^{8 9 10 11 12}

What is the purpose of this trial?

Cochlear implants are surgically implanted devices which restore the ability to hear to the hearing impaired. Improvements in surgery and electrodes have results in an increased number of adults and children who have residual hearing and can benefit from electric and acoustic hearing in the same ear. This is called Electric Acoustic Stimulation (EAS). Many studies have shown that adult EAS users show significant benefits for speech understanding in noise and spatial hearing tasks as compared to a CI paired only with a contralateral HA. Even though this type of hearing is becoming more common, there is limited research on how it can be beneficial to children with CIs. The benefits of this study are a greater understanding of the participant's speech understanding, binaural processing, and spatial hearing. The results will help audiologists and researcher better understand how cochlear implants work, specifically when using electric and acoustic hearing in the same ear.

Research Team

Jourdan T Holder, AuD, PhD

Principal Investigator

Vanderbilt University Medical Center

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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?

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+

Findings from Research

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]

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]

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 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]

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]

References

1. England pubmed.ncbi.nlm.nih.gov

EAS-Combined electric and acoustic stimulation. [2021]

2. Switzerland pubmed.ncbi.nlm.nih.gov

Combined electric and acoustic stimulation of the auditory system: results of a clinical study. [2022]

3. Netherlands pubmed.ncbi.nlm.nih.gov

Representation of acoustic signals in the human cochlea in presence of a cochlear implant electrode. [2006]

4. United States pubmed.ncbi.nlm.nih.gov

Effects of the Configuration of Hearing Loss on Consonant Perception between Simulated Bimodal and Electric Acoustic Stimulation Hearing. [2022]

5. United States pubmed.ncbi.nlm.nih.gov

The influence of different speech processor and hearing aid settings on speech perception outcomes in electric acoustic stimulation patients. [2007]

6. United States pubmed.ncbi.nlm.nih.gov

Multicenter US Clinical Trial With an Electric-Acoustic Stimulation (EAS) System in Adults: Final Outcomes. [2019]

7. Brazil pubmed.ncbi.nlm.nih.gov

Electro acoustic stimulation of the auditory system: UNICAMP's surgical approach. [2022]

8. United States pubmed.ncbi.nlm.nih.gov

Safety and performance of the EverProTM everolimus-eluting coronary stent system with biodegradable polymer in a real-world scenario. [2021]

9. China (Republic : 1949- ) 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. [2022]

10. Ireland pubmed.ncbi.nlm.nih.gov

12-Month clinical outcomes of amphilimus drug eluting stents in an all-comers South-East Asian registry. [2022]

11. United States pubmed.ncbi.nlm.nih.gov

Clinical outcomes in the percutaneous coronary intervention of in-stent restenosis with everolimus-eluting stents. [2015]

12. United States 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. [2022]