Cochlear Implant + Hearing Aid for Hearing Loss
Recruiting in Palo Alto (17 mi)
+2 other locations
Age: Any Age
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Academic
Recruiting
Sponsor: Vanderbilt University Medical Center
Disqualifiers: Autism, Auditory neuropathy, Neurological disorder, others
No Placebo Group
Approved in 2 Jurisdictions
Trial Summary
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.
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%.
12345Is 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.
12367How 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.
89101112Eligibility 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.
+4 more
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.
Trial 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
Participant Groups
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.
4Treatment groups
Experimental Treatment
Active Control
Group I: Pediatric use of EASExperimental Treatment1 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 EASExperimental Treatment1 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 HearingActive Control1 Intervention
Children with normal hearing; acoustic only
Group IV: Adults with Normal HearingActive Control1 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
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
University Of Texas at AustinAustin, TX
Vanderbilt University Medical CenterNashville, TN
University Of Wisconsin MadisonMadison, WI
Loading ...
Who Is Running the Clinical Trial?
Vanderbilt University Medical CenterLead Sponsor
National Institute on Deafness and Other Communication Disorders (NIDCD)Collaborator
References
EAS-Combined electric and acoustic stimulation. [2021]Electric-acoustic stimulation (EAS) is a special treatment modality for those patients who are profoundly deaf in the high-frequency (HF) region and retain usable hearing in the low-frequency (LF) region. Combining the electric stimulation with cochlear implant (CI) in the HF and acoustic amplification of residual hearing using a conventional hearing aid (HA) in the LF region defines EAS. The EAS concept was first proposed by C. von Ilberg from Frankfurt, Germany in the year 1997. In association with MED-EL, all the necessary safety studies were performed in non-human subjects before the first patient received it in 1997. In association with MED-EL, all the necessary safety studies were performed in non-human subjects before the first patient received it in 1999. For the patient to successfully use the EAS concept, the residual hearing needs to be preserved to a high extent and for several years. This requires a highly flexible electrode array in safeguarding the intra-cochlear structures during and after the CI electrode array insertion. Combining the HA unit with the audio processor unit of the CI was necessary for the convenient wearing of the unified audio processor. Fitting of the unified audio processor is another important factor that contributes to the overall success of the EAS treatment. The key translational research efforts at MED-EL were on the development of flexible electrodes, a unified audio processor, innovations in the fitting process, intra-operative monitoring of cochlear health during electrode insertion, pre-operative soft-ware tool to evaluate the cochlear size and electrode selection and some new innovations tried within EAS topic. This article covers the milestones of translational research from the first concept to the widespread clinical use of EAS.
Combined electric and acoustic stimulation of the auditory system: results of a clinical study. [2022]Combined electric and acoustic stimulation (EAS) of the auditory system is a new therapy for patients with severe to profound high- and mid-frequency hearing loss but remaining low-frequency hearing. In a prospective study, 13 patients with low-frequency hearing of better than 60 dB below 1 kHz were implanted with a MED-EL COMBI 40+ cochlear implant. Pure tone thresholds as well as monosyllabic word scores and Hochmair-Schulz-Moser sentences in quiet and in noise were measured with hearing aids, cochlear implant alone and in the combined stimulation mode (EAS) in the same ear. Hearing could be partially preserved in 11 out of the 13 patients. All patients scored significantly higher with cochlear implant alone than with hearing aids. Seven patients scored higher in the EAS mode than with cochlear implant alone for sentences in noise, 4 remained unchanged, and 2 could not use EAS. Synergistic effects of EAS were most prominent for hearing in noise with increases of up to 72% as compared to cochlear implant alone.
Representation of acoustic signals in the human cochlea in presence of a cochlear implant electrode. [2006]In subjects with remaining low frequency hearing, combined electric-acoustic stimulation (EAS) of the auditory system is a new therapeutic perspective. Intracochlear introduction of a cochlear implant electrode, however, may alter the biomechanical properties of the inner ear and thus affect perception of acoustic stimuli.
Effects of the Configuration of Hearing Loss on Consonant Perception between Simulated Bimodal and Electric Acoustic Stimulation Hearing. [2022]Cochlear implant technology allows for acoustic and electric stimulations to be combined across ears (bimodal) and within the same ear (electric acoustic stimulation [EAS]). Mechanisms used to integrate speech acoustics may be different between the bimodal and EAS hearing, and the configurations of hearing loss might be an important factor for the integration. Thus, differentiating the effects of different configurations of hearing loss on bimodal or EAS benefit in speech perception (differences in performance with combined acoustic and electric stimulations from a better stimulation alone) is important.
The influence of different speech processor and hearing aid settings on speech perception outcomes in electric acoustic stimulation patients. [2007]Electric acoustic stimulation (EAS) is an increasingly popular means of treating individuals with a steeply sloping mid-to-high frequency hearing loss, who traditionally do not benefit from hearing instruments. These persons often have too much residual hearing to be considered for a cochlear implant. Several studies have demonstrated the ability both to preserve the remaining low-frequency hearing in these individuals, and to provide significant benefit through combining a cochlear implant with a hearing aid to amplify the same ear. These improvements in performance have been especially noted in noise. Often overlooked is that these outcomes may be influenced by the fitting parameters of both the cochlear implant and the hearing aid.
Multicenter US Clinical Trial With an Electric-Acoustic Stimulation (EAS) System in Adults: Final Outcomes. [2019]To demonstrate the safety and effectiveness of the MED-EL Electric-Acoustic Stimulation (EAS) System, for adults with residual low-frequency hearing and severe-to-profound hearing loss in the mid to high frequencies.
Electro acoustic stimulation of the auditory system: UNICAMP's surgical approach. [2022]A new era has arrived in auditory rehabilitation with the introduction of new technologies such as electroacoustic stimulation (EAS). EAS is indicated for patients with residual hearing at low frequencies and severe or profound hearing loss at high frequencies. These patients have no indication for conventional cochlear implant and have difficulties in adapting to individual sound amplification devices. Preservation of hearing is vital in this process; the surgical technique must be based on this concept.
Safety and performance of the EverProTM everolimus-eluting coronary stent system with biodegradable polymer in a real-world scenario. [2021]Label="BACKGROUND" NlmCategory="BACKGROUND">The EverProTM (Sahajanand Laser Technology Ltd., India) everolimus-eluting coronary stent system (EES) is a second-generation drug-eluting stent with a biodegradable polymer.
Vascular Healing Response after Everolimus-Eluting Stent Implantation in Acute Coronary Syndrome Culprit Lesions: Comparison with Implantation in Stable Angina Pectoris. [2022]To evaluate the neointimal conditions of everolimus-eluting stents (EESs) implanted in culprit lesions of patients with acute coronary syndrome (ACS) compared with stable angina pectoris (SAP) using optical coherence tomography (OCT). EESs are second-generation drug-eluting stents that have recently been shown to be useful in patients with ACS as well as in patients with SAP. However, few studies have analyzed the intra-stent conditions of EESs that can lead to favorable results in such ACS lesions.
12-Month clinical outcomes of amphilimus drug eluting stents in an all-comers South-East Asian registry. [2022]Amphilimus-eluting stent (AES) is a novel polymer-free drug eluting stent that combines sirolimus with fatty acid as antiproliferative drug and has shown promising results in percutaneous coronary intervention.We evaluated the clinical safety and efficacy of AES in an all-comers South-East Asian registry.
Clinical outcomes in the percutaneous coronary intervention of in-stent restenosis with everolimus-eluting stents. [2015]Although percutaneous coronary intervention with everolimus-eluting stent (EES) implantation for native coronary artery disease has favorable results compared to first-generation drug-eluting stents, outcomes with EES for the treatment of in-stent restenosis (ISR) are unknown.
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]Data regarding vessel healing by optical coherence tomography (OCT) after everolimus-eluting bioresorbable scaffolds (BRS) or everolimus-eluting metallic stent (EES) implantation in acute myocardial infarction (AMI) patients is scarce. We compared OCT findings after BRS or EES implantation in patients with AMI enrolled in a randomized trial.