Clinical Trials

The purpose of the study is to evaluate performance of the Acclaim Cochlear Implant System (“System”) and determine what design changes, if any, are required to optimize performance prior to a pivotal study.

In 1985, the United States Food and Drug Administration (FDA) approved multichannel cochlear implants (CIs) for adults with profound hearing loss; and in 1990, implantation was approved for children. Since then, this procedure has become the standard of care for patients with severe-to-profound sensorineural hearing loss. Successful outcomes are dependent not only on extrinsic factors, but also on intrinsic factors that cannot always be modified by the CI team. Significant predictive factors for hearing outcomes in patients with CIs have been previously reported. These include, but are not limited to, duration of deafness, level of preimplant speech recognition, pre/postlingual status, ...

The purpose of this study is to determine the effect of fluctuating electrode impedances on speech perception in cochlear implants.

Do adults and older children (greater than 7 years of age) with unilateral or assymetric hearing loss benefit from cochlear implantation on the worst hearing side.

This is not a funded study. All costs are billed through insurance for reimbursement. There is an insurance approval process that we move through after a participant has been evaluated at the Mayo Clinic and found to be a candidate for cochlear implantation.

The purpose of this study is to determine if adults using the MedEL Flex 28 cochlear implant derive greater benefit from temporal cues when they are coded by fewer numbers of apical electrodes.

The purpose of this study is to correlate scalar localization of the electrode array with intra-operative observations in an effort to advance surgical technique, intra-operative monitoring and device design to improve post-operative hearing outcomes.

The purpose of this feasibility study is to evaluate whether low-frequency acoustic hearing sensitivity can be preserved in newly implanted adults with partial deafness (considerable low frequency acoustic hearing profiles with severe-to-profound high frequency sensorineural hearing loss) using the HiResolution™ 90K™ Advantage cochlear implant with the HiFocus™ Mid-Scala electrode to support the development of electro-acoustic stimulation technology (EAS).

This study is being done to learn more about the development of the auditory skills in children with bilateral cochlear implants.

The purpose of this study is to determine if aural rehabilitation adds measurable benefit and participant satisfaction to a cochlear implant recipient's overall treatment. Also, the study is designed to compare the efficacy of a commercially available aural rehabilitation program (LACE) and an electronic program which takes advantage of a traditional form of auditory training (NOOK) for cochlear implant users.

The purpose of this study is to evaluate the feasibility of highly coordinated care model in cochlear implantation (CI), to determine the impact of new care delivery model on the patient care experience, and to evaluate financial and implementation implications of highly coordinated care in cochlear implantation.

To determine if changes in cochlear implant electrode impedances change as a function current level and charge that is used to measure electrode impedances.

The purpose of this study is to determine changes in cochlear implant electrode impedances as a function over a period of time.

The primary objective of this study is to determine the hearing preservation advantage, defined as the increased chance of preservation of residual hearing (i.e., low frequency pure tone average ≤ 80 dB HL), of ECochG-guided CI electrode insertions in EAS candidates.

The purpose of this study is to determine if electrocochleography (ECochG) measurements performed during cochlear implant surgery can be used to monitor cochlear structures and minimize electrode insertion trauma.

The purpose of this study is to evaluate how the benefit obtained from using a directional microphone like StereoZoom in noise varies with location of the speech source (functional directionality).

The purpose of this study is to determine whether speech recognition in noise can be improved by the addition of a special listening program to the sound processor. Thus we propose to assess speech perception in noise for pediatric cochlear implant patients using both their everyday listening program as well an autosensitivity program.

The purpose of this study is show the effectiveness of a dexamethasone eluting electrode in an adult population with post-lingual, bilateral, moderate to profound sensorineural hearing loss in the reduction of fibrosis (as measured by impedance) when compared to a conventional, non-dexamethasone eluting electrode and in the improvement of speech recognition from preoperative baseline.

The purpose of this study is to design and develop a wearable amplification device with the capability of an extended high frequency range for improved fidelity, directionality, noise cancellation, and surround sound. 

Noninvasive electrostimulation of the cochlea has notable benefits for normal hearing and hearing-impaired individuals that extend well-beyond conventional acoustic and bone conducted enhancements of sound.  Although the technique has been known since the 19th century little clinical attention or application of the technique has occurred, particularly related to a wearable technology for individual use.  

The purpose of this study is to analyze clinical and audiological outcomes in a large cohort of cochlear implant recipients implanted at the Mayo Clinic since its initiation in 1982.

The purpose of this study is to perform electrophysiological (inner ear) measurements to assess hearing function in cochlear implant patients.

Hypothesis: Cochlear implant and Auditory Brainstem Implant outcomes continue to improve secondary to improved device design, surgical approach, and advanced programming.