Cochlear Implant Programming 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: Massachusetts Eye and Ear Infirmary
Disqualifiers: Hearing loss, Informed consent, others
No Placebo Group
Approved in 4 Jurisdictions
Trial Summary
What is the purpose of this trial?Despite the success of cochlear implants, devices surgically placed in the inner ears of patients with severe hearing loss, there remains substantial variability in the overall speech perception outcomes for the children and adults who receive them. The main goals of this project are: i) to improve our understanding of how cochlear implants affect the developing auditory system, ii) apply that knowledge to test new methods for programming children and adults, and iii) to study how long it takes listeners to adapt to new cochlear implant programs over the short- and long-term. The results will improve our understanding of how the deafened auditory system develops with cochlear implant stimulation and advance clinical practice to improve hearing outcomes in cochlear implant listeners.
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 Cochlear Implant Electrode-neuron Interfaces, Cochlear Implant, Bionic Ear, Auditory Implant for hearing loss?
Research shows that cochlear implants, which are devices that help provide hearing to deaf patients, can be effective, although results vary. Studies on animals and humans indicate that different electrode designs and configurations can improve hearing outcomes by better stimulating the auditory nerve and reducing interference between electrodes.
12345Is the cochlear implant generally safe for humans?
Research shows that cochlear implants are generally safe for humans. The materials used are compatible with the body, and the device can be inserted and removed with minimal trauma. Long-term use has not shown harmful effects on hearing-related cells in patients.
678910How is the Cochlear Implant Electrode-neuron Interfaces treatment different from other treatments for hearing loss?
Cochlear Implant Electrode-neuron Interfaces are unique because they bypass damaged parts of the ear and directly stimulate the auditory nerve using an array of electrodes, which is different from hearing aids that simply amplify sound. This treatment involves advanced technology like multi-channel arrays and precise electrode placement to improve hearing, especially for those with severe to profound hearing loss.
211121314Eligibility Criteria
This trial is for children and adults with severe hearing loss who have cochlear implants from specific manufacturers. Adults must be at least 18, native English speakers, while children can participate from 6 months old. Participants cannot join if they're unable to consent or meet certain protocol criteria like age of hearing loss onset.Inclusion Criteria
I have a cochlear implant and fit the specific age criteria for hearing loss or implantation.
My child is over 6 months old, speaks American English, and has a cochlear implant from Advanced Bionics, Cochlear, or MED-EL.
I am 18 or older, speak American English, and wear a cochlear implant from Advanced Bionics, Cochlear, or MED-EL.
Exclusion Criteria
Exclusion for all Cochlear Implant Subjects: Inability to provide informed consent, does not meet the inclusion criteria for a specific study protocol, such as age of onset of hearing loss, age of cochlear implantation, duration of deafness, number of active electrodes in the cochlear implant device, unable to carry out the study protocol or tasks required in the study
Exclusion for all Normal Hearing Subjects: Inability to provide informed consent, hearing loss, or significant history of hearing related issues, unable to carry out the study protocol or tasks required in the study
Trial Timeline
Screening
Participants are screened for eligibility to participate in the trial
2-4 weeks
Treatment
Participants receive experimental cochlear implant programming and are assessed weekly for 10 weeks
10 weeks
Weekly visits (in-person)
Follow-up
Participants are monitored for safety and effectiveness after treatment
4 weeks
Participant Groups
The study aims to understand how cochlear implants affect auditory development and test new programming methods for better speech perception in users. It involves cognitive assessments, threshold and psychophysical testing, speech tests, and telemetry recordings over time.
3Treatment groups
Experimental Treatment
Active Control
Placebo Group
Group I: Performance Assessed with Experimental Sound Processing StrategyExperimental Treatment1 Intervention
Patients listening to experimental cochlear implant processing strategy.
Group II: ControlActive Control1 Intervention
Patients listening to their clinical cochlear implant using their "own" processor (their everyday listening situation).
Group III: Experimental ControlPlacebo Group1 Intervention
Patients listening to experimental cochlear implant using a processing strategy like thier clinical program, a "clinical like" program.
Cochlear Implant Electrode-neuron Interfaces is already approved in European Union, United States, Canada, Australia for the following indications:
🇪🇺 Approved in European Union as Cochlear Implant for:
- Severe to profound sensorineural hearing loss
🇺🇸 Approved in United States as Cochlear Implant for:
- Severe to profound sensorineural hearing loss
- Single-sided deafness
🇨🇦 Approved in Canada as Cochlear Implant for:
- Severe to profound sensorineural hearing loss
🇦🇺 Approved in Australia as Cochlear Implant for:
- Severe to profound sensorineural hearing loss
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
Mass General BrighamBoston, MA
Mass Eye and EarBoston, MA
Boston Children's HospitalWaltham, MA
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Who Is Running the Clinical Trial?
Massachusetts Eye and Ear InfirmaryLead Sponsor
University of WashingtonCollaborator
Boston Children's HospitalCollaborator
References
Cochlear nerve stimulation with a 3-dimensional penetrating electrode array. [2019]An array of penetrating microelectrodes can be implanted into the cochlear nerve to produce stable evoked responses with important electrophysiologic advantages over conventional electrode technology.
Development of a novel eighth-nerve intraneural auditory neuroprosthesis. [2016]Cochlear nerve stimulation using a linear array of electrodes, the cochlear implant, has become an accepted treatment for profound deafness. Major limitations of this technology are high threshold of stimulation, poor performance in a noisy background, cross-talk between electrodes, unsatisfactory channel selectivity, and variable reconstruction of frequency space. A novel auditory neuroprosthesis is proposed that is expected to overcome these problems by implanting an array of three-dimensional microelectrodes, the Utah Electrode Array, directly into the cochlear nerve.
Matched Cohort Comparison Indicates Superiority of Precurved Electrode Arrays. [2020]Characterize differences in adult cochlear implant outcomes and programming parameters for a straight (CI422/522) and a precurved (CI532) electrode array.
A physiological and behavioral system for hearing restoration with cochlear implants. [2019]Cochlear implants are neuroprosthetic devices that provide hearing to deaf patients, although outcomes are highly variable even with prolonged training and use. The central auditory system must process cochlear implant signals, but it is unclear how neural circuits adapt-or fail to adapt-to such inputs. The knowledge of these mechanisms is required for development of next-generation neuroprosthetics that interface with existing neural circuits and enable synaptic plasticity to improve perceptual outcomes. Here, we describe a new system for cochlear implant insertion, stimulation, and behavioral training in rats. Animals were first ensured to have significant hearing loss via physiological and behavioral criteria. We developed a surgical approach for multichannel (2- or 8-channel) array insertion, comparable with implantation procedures and depth in humans. Peripheral and cortical responses to stimulation were used to program the implant objectively. Animals fitted with implants learned to use them for an auditory-dependent task that assesses frequency detection and recognition in a background of environmentally and self-generated noise and ceased responding appropriately to sounds when the implant was temporarily inactivated. This physiologically calibrated and behaviorally validated system provides a powerful opportunity to study the neural basis of neuroprosthetic device use and plasticity.
Functional responses from guinea pigs with cochlear implants. I. Electrophysiological and psychophysical measures. [2019]We examined electrophysiological and psychophysical measures of the electrically stimulated auditory system of guinea pigs implanted with chronic intracochlear electrodes. Guinea pigs were trained to detect low-level acoustic stimuli and then unilaterally deafened and implanted with one extracochlear and two intracochlear electrodes. Electrically evoked auditory brainstem responses (EABRs) and psychophysical detection thresholds were obtained from the same animals using pulsatile stimuli. Supplementary EABR data were obtained from additional, untrained, animals. Thresholds were obtained as a function of stimulus phase duration and monopolar and longitudinal-bipolar electrode configurations. The slopes of the EABR and psychophysical functions for bipolar stimulation, averaged across subjects within 1 month after implantation, were -5.25 and -6.18 dB per doubling of pulse duration, respectively. These slopes were obtained with pulse durations ranging from 20 to 400 microseconds/phase; slope was reduced at longer pulse durations. Strength-duration slope also varied as a function of electrode configuration: monopolar stimulation produced steeper functions than did bipolar stimulation. Differences between EABR and psychophysical strength-duration measures suggest the existence of central mechanisms of stimulus integration in addition to that occurring at the level of the auditory nerve. Differences observed with variation of stimulus parameters (e.g., monopolar vs. bipolar stimulation modes) suggest that the specific mode of intracochlear electrical stimulation can influence stimulus integration. Such observations may be useful in the design of prosthetic devices and furthering our understanding of electrical excitation of the auditory system.
The biologic safety of the Cochlear Corporation multiple-electrode intracochlear implant. [2006]Studies have been undertaken to confirm the biologic safety of the Cochlear Corporation multi-electrode intracochlear implant. The materials used are biocompatible. The electrode array is flexible: it can be inserted with minimal or no trauma, providing the insertion is stopped when resistance is first felt. An atraumatic insertion is facilitated if a good view is obtained along the scala tympani of the basal turn of the cochlea by drilling through the crista fenestrae. The passage of the electrode around the cochlea can be facilitated if the electrode is rotated during insertion (clockwise for the left and anticlockwise for the right cochlea). The electrode can be explanted and another one reinserted with minimal or no trauma. A seal established around the electrode after an implantation period of 2 weeks can prevent infection extending from the middle to the inner ear. The electrical stimulus parameters produced by the Nucleus receiver-stimulator cause no loss of spiral ganglion cells or corrosion of the platinum band electrodes. Long-term stimulation has been carried out for up to 8 years in patients without affecting their clinical performance.
HiRes ultra series cochlear implant field recall: failure rates and early outcomes. [2023]Evaluate rates of Advanced Bionics Ultra 3D/Ultra cochlear implant failure in the setting of a worldwide device recall and report surgical and auditory outcomes after revision.
An evaluation framework for research platforms to advance cochlear implant/hearing aid technology: A case study with CCi-MOBILE. [2022]Cochlear implants (CIs) and hearing aids (HAs) are advanced assistive hearing devices that perform sound processing to achieve acoustic to acoustic/electrical stimulation, thus enabling the prospects for hearing restoration and rehabilitation. Since commercial CIs/HAs are typically constrained by manufacturer design/production constraints, it is necessary for researchers to use research platforms (RPs) to advance algorithms and conduct investigational studies with CI/HA subjects. While previous CI/HA research platforms exist, no study has explored establishing a formal evaluation protocol for the operational safety and reliability of RPs. This study proposes a two-phase analysis and evaluation paradigm for RPs. In the acoustic phase 1 step, a signal processing acoustic space is explored in order to present a sampled set of audio input content to explore the safety of the resulting output electric/acoustic stimulation. In the parameter phase 2 step, the configurable space for realizable electrical stimulation pulses is determined, and overall stimulation reliability and safety are evaluated. The proposed protocol is applied and demonstrated using Costakis Cochlear Implant Mobile. Assessment protocol observations, results, and additional best practices for subsampling of the acoustic and parameter test spaces are discussed. The proposed analysis-evaluation protocol establishes a viable framework for assessing RP operational safety and reliability. Guidelines for adapting the proposed protocol to address variability in RP configuration due to experimental factors such as custom algorithms, stimulation techniques, and/or individualization are also considered.
Efficacy of the Bonebridge BCI602 for Adult Patients with Single-sided Deafness: A Prospective Multicenter Study. [2023]To investigate the safety and efficacy of a novel active transcutaneous bone conduction implant (BCI) device for patients with single-sided deafness (SSD).
[Cochlear pathology following chronic electrical stimulation in cats]. [2007]This study is to follow the faults during safe research of chronic electrical stimulation of auditory nerve. They were surgical trauma; electrode excursion from scala tympani in different periods after insertion, direct current trauma to the cochleas during chronic electrical stimulation due to the stimulator fault. Extensive histopathological changes were observed, including widespread hair cell and spiral ganglion loss and new bone growth. These results have important implications both in the use and design of cochlear prostheses.
[General principles of conception of cochlear implants]. [2006]Cochlear implants have greatly been developed on last ten years. Their diversity makes their use and choice more complex. The authors expose simply the physiopathology of the implanted auditory system and basic principles of cochlear implants. Cochlear implants are caracterised by the number of channels and electrodes (monochannel, multichannel), the strategy of encoding (analogiq, digital), the transmission of signal (per-cutaneous, electro-magnetic induction), the site of stimulation (extra or intra-cochlear), the signal wave (sinusoid, pulse), the diffusion of current (monopolar, bipolar).
Cochlear implant programming. [2011]Cochlear implants have become a viable treatment option for individuals who present with severe to profound hearing loss. While there are several parameters that affect the successful use of this technology, quality programming of the cochlear implant system is crucial. This review chapter focuses on general device programming techniques, programming techniques specific to children, objective programming techniques, a brief overview of programming parameters of the currently commercially available multichannel systems, and managing patient complaints and device failures. The chapter also provides what the authors believe the future may hold for new programming techniques.
Cochlear electrode arrays: past, present and future. [2007]Cochlear implants are very successful devices: more than 60000 people use them throughout the world. Key to the success of these prostheses is the development of electrode arrays that place contacts close to the target neurons, survive for decades in the tissues of the inner ear, and that provide reliable and repeatable excitation to the cells of the auditory nerve. This article describes the early electrode arrays and their development into the arrays that are used presently in clinical cochlear prostheses. While integrated circuit techniques were proposed and tested in the laboratory two decades ago, the present clinical devices still are hand built and made of wire-based technologies. Current approaches that seek to automate the construction of cochlear electrode arrays are described and discussed.
Bioengineering applications for hearing restoration: emerging biologically inspired and biointegrated designs. [2022]Cochlear implantation has become the standard of care for hearing loss not amenable to amplification by bypassing the structures of the cochlea and stimulating the spiral ganglion neurons directly. Since the first single channel electrodes were implanted, significant advancements have been made: multi-channel arrays are now standard, they are softer to avoid damage to the cochlea and pre-curved to better position the electrode array adjacent to the nerve, and surgical and stimulation techniques have helped to conform to the anatomy and physiology of the cochlea. However, even with these advances the experience does not approach that of normal hearing. In order to make significant advances in performance, the next generation of implants will require novel interface technology. Advances in regenerative techniques, optogenetics, piezoelectric materials, and bioengineered living scaffolds hold the promise for the next generation of implantable hearing devices, and hope for the restoration of natural hearing.