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NCT06305039

Optimizing Bilateral and Single-sided-deafness Cochlear Implants for Functioning in Complex Auditory Environments

Enrolling by Invitation
NAAges 18–85InterventionalBasic science
University of Maryland, College Park
~300 participants
Updated 2025-03-28 on ClinicalTrials.gov
What's tested:Diagnostic tests of cochlear implant or acoustic hearing functionTargeted aural rehabilitation of the poorer performing ear

At a glance

Recruiting sites
0 of 2 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Perceptual responses to sound level
Measured over Post-treatment - after at least 6 months use of a cochlear implant if CI user. After enrollment for non-implanted listeners with acoustic hearing.
+4 more outcomes measured

Conditions

Hearing Loss
Hearing Loss, Sensorineural
Cochlear Hearing Loss

Explore related trials

Hearing LossSensorineural Hearing LossSensory Hearing LossSingle-Sided Deafness

Where it's being run

2 sites across 1 states
Maryland2

Study leadership

  • Matthew J. Goupell, PhD · PRINCIPAL_INVESTIGATOR · University of Maryland, College Park
  • Joshua G. Bernstein, PhD · PRINCIPAL_INVESTIGATOR · Walter Reed National Military Medical Center; University of Maryland, College Park

Who to contact

This trial hasn't published a contact. View it on ClinicalTrials.gov

Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

two cochlear implants
acquired their hearing loss during adulthood or late childhood (post-lingual onset)
native English speaker
primarily use oral language
at least six months of cochlear implant use
Sufficient corrected or uncorrected visual acuity (20/50 or better) to read large-font text
one cochlear implant in one ear and a second ear with some acoustic hearing
acquired their hearing loss during adulthood or late childhood (post-lingual onset)
native English speaker
primarily use oral language
at least six months of cochlear implant use
Sufficient corrected or uncorrected visual acuity (20/50 or better) to read large-font text
audiometrically normal hearing or near-normal hearing, or mild/moderate hearing loss
Sufficient corrected or uncorrected visual acuity (20/50 or better) to read large-font text

Exclusion

people who do not use oral language will be excluded.
people with less than six months of device use will be excluded
other known disability or neurological disorder
women who are pregnant will be excluded from the CT portion of the study
people with any unaided audiometric tone-detection threshold better than 60 dB HL at standard audiometric frequencies (250-8000 Hz) in either ear will be excluded
people who do not use oral language will be excluded.
people with less than six months of device use will be excluded
other known disability or neurological disorder
women who are pregnant will be excluded from the CT portion of the study
people with any unaided audiometric tone-detection threshold better than 60 dB HL at standard audiometric frequencies (250-8000 Hz) in the implanted ear will be excluded
people with an acoustic pure-tone average threshold (octave frequencies 250-4000 Hz) \> 30 dB HL in the non-implanted ear
severe hearing loss
other known disability or neurological disorder

What this trial measures

  • Perceptual responses to sound levelPost-treatment - after at least 6 months use of a cochlear implant if CI user. After enrollment for non-implanted listeners with acoustic hearing.

    Interaural loudness mismatch is defined as the difference between the levels required to balance interaural loudness for sequential stimulation and the levels required to perceptually center a sound image in space for simultaneous stimulation. Participants will respond through pressing virtual buttons on a computer screen. Depending on the condition tested, the sounds will be delivered to one or both ears.

  • Speech understanding in the presence of masking soundsPost-treatment - after at least 6 months use of a cochlear implant if CI user. After enrollment for non-implanted listeners with acoustic hearing.

    Speech understanding will be assessed as the percentage of correctly identified keywords. Subjects will respond through oral report (where the responses will be scored by the experimenter) or through pressing virtual buttons on a computer screen. The speech sounds will be delivered to one or both ears in the presence of different types of masking sounds. In some cases, signal processing techniques will be used to distort the speech signals to simulate asymmetric hearing abilities.

  • Computed-tomography scanFor CI users: CT scan will be collected from existing medical records with permission or taken after study enrollment. Measurements taken after study enrollment. Not collected for non-implanted listeners with acoustic hearing.

    A computed tomography temporal bone scan will be used to image the cochlear structures and cochlear implant electrode array located within. This scan will use a standard clinical scanner, with software updated to extend the Hounsfield range to reduce artifact from the metal contacts of the electrode array. This procedure uses radiographic processes, and therefore presents the subject with a safe but nonzero amount of radiation. The CT scan will be analyzed to provide measurements of each array's insertion depth within the cochlea (in degrees and mm), the distance to the cochlear modiolus (mm), and cochlear scalar location.

  • Electrode impedance (transelectrode impedance matrix)Post-treatment - after at least 6 months use of a cochlear implant if CI user. Not collected for non-implanted listeners with acoustic hearing.

    This standard clinical measurement will apply a current to one electrode, and measure the resulting induced voltage at each of the other electrodes in the array, one at a time. This process uses low-level electrical stimulation only intended to measure the impedance of the intervening tissues and fluids of the cochlea, and is rarely even perceived by the subject.

  • Electrically evoked compound action potentials (ECAPs)Post-treatment - after at least 6 months use of a cochlear implant if CI user. Not collected for non-implanted listeners with acoustic hearing.

    Electrically evoked compound action potentials (ECAPs) will be measured using clinically-available software to track the growth in auditory nerve response (observed \~0.2-0.8 ms post-stimulus onset) as input level is varied from threshold to the maximal level at which the signal is comfortably loud. The slope of input-output function will be measured ( in microvolts/current unit) for each electrode along the electrode array of each cochlear implant study participant.