grant

Clinical Utility of Residual Hearing in the Cochlear Implant Ear

Organization OHIO STATE UNIVERSITYLocation Columbus, UNITED STATESPosted 1 Aug 2020Deadline 31 Jul 2026
NIHUS FederalResearch GrantFY2024Acoustic StimulationAcousticsAddressAlgorithmsAuditoryAuditory StimulationBiological MarkersClinicalCochleaCochlear ImplantationCochlear ImplantsCochlear OrganCochlear ProsthesisCochlear Prosthesis ImplantationCochlear implant procedureEarElectrocochleographiesElectrodesElectrophysiologyElectrophysiology (science)EligibilityEligibility DeterminationEnrollmentFeedbackGoalsHearingHearing AidsHearing LossHypoacusesHypoacusisImplantImplanted ElectrodesIntraoperative MonitoringIpsilateralKnowledgeLiteratureMeasuresMethodsMonitorMusicNeurophysiology / ElectrophysiologyNoiseOperative ProceduresOperative Surgical ProceduresOutcomeOutcome MeasurePatientsPerceptionPerformancePositionPositioning AttributePost-OperativePostoperativePostoperative PeriodProbabilityProtocolProtocol ScreeningProtocols documentationQOLQuality of lifeRandomizedReportingResidualResidual stateSecondary toSpeech PerceptionSurgeonSurgicalSurgical InterventionsSurgical ProcedureSystemTechnologyTimeTraumaarmassistive hearing deviceassistive listening devicebio-markersbiologic markerbiomarkerclinical practicedesigndesigningdysfunctional hearingelectrophysiologicalenrollevidence basefunctional statushearing amplificationhearing assistancehearing assistive devicehearing challengedhearing defecthearing deficienthearing deficithearing devicehearing difficultyhearing dysfunctionhearing impairmenthearing preservationimplantationimprovedimproved outcomeintra-operative monitoringmeasurable outcomenew technologynovel technologiesoutcome measurementpreservationpreserve hearingrandomisationrandomizationrandomly assignedsurgery
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Full Description

Abstract
A major concern in cochlear implantation is the loss of residual hearing associated with surgery. Hence,

many candidates are faced with the decision to relinquish their remaining acoustic hearing in exchange for

electric hearing via the cochlear implant (CI). A potential solution is a stimulation strategy termed Electric acoustic

stimulation (EAS), which has been used to describe the ipsilateral combination of electric hearing via a CI and

acoustic hearing via a hearing aid. This, however, requires preservation of residual hearing, which has been

possible but inconsistent. A new technology to potentially improve hearing preservation, intraoperative

electrocochleography (ECochG), has been introduced and it was recently implemented into commercially

available CI systems.

Studies comparing EAS with conventional CI have were able to demonstrate a performance benefit of EAS.

However, these studies have compared conventional CI candidates to EAS candidates with more residual

hearing. Thus, the clinical importance of residual acoustic hearing in cochlear implantation (CI) remains unclear.

Therefore, the present protocol seeks to answer two critical clinical questions in cochlear implantation:

(Specific Aim 1) Are cochlear implant electrode insertions using Electrocochleography (ECochG) feedback better

for achieving hearing preservation (HP) and (Specific Aim 2) is combined ipsilateral EAS better than non-HP

(conventional) cochlear implantation among CI candidates with substantial residual hearing (EAS candidates).

We plan to enroll and randomize EAS candidates in seven large US centers. Patients will be assigned to

either intraoperative ECochG monitoring or conventional CI electrode insertions. Hearing preservation and other

performance outcomes will be recorded and analyzed between the groups to assess the clinical value of

intraoperative monitoring. Further, subjects from both groups will have either useable or no useable residual

hearing as the result of surgery. Audiometric and patient reported performance outcomes will be obtained and

evaluated for 24 months following initial stimulation.

In summary, the present proposal aims to answer two critical clinical questions: Is CI electrode insertion

based on ECochG better for achieving HP? and Is EAS better than conventional cochlear implantation among

EAS candidates? A positive answer to these questions will inform an evidence-based clinical practice for EAS

candidates that uses longer electrodes, broadens the candidate pool by including patients with greater levels of

residual hearing, and potentially improves outcomes following CI.

Grant Number: 5U01DC018920-05
NIH Institute/Center: NIH

Principal Investigator: Oliver Adunka

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