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Completed

NCT Number: NCT02811549

Benefits of the HiResolution Bionic Ear System in Adults With Asymmetric Hearing Loss

The purpose of this feasibility study is to evaluate the benefit of unilateral implantation in adults who have severe to profound sensorineural hearing loss in one ear, and up to moderate sensorineural hearing loss in the other ear (asymmetric hearing loss).

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Key information

Conditions

Hearing Loss Asymmetrical Hearing Loss Ear Diseases Hearing Disorders Nervous System Diseases Neurologic Manifestations Otorhinolaryngologic Diseases Pathological Conditions, Signs and Symptoms Sensation Disorders Signs and Symptoms Single-sided Deafness

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

The Silverstein Institute, Sarasota, Florida, United States

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

General Requirements:

  • Ability to provide Informed Consent
  • 18 years of age or older
  • English language proficiency
  • Willingness to participate in all scheduled procedures outlined in the study investigational plan
  • Willingness to use an approved cochlear implant signal processing strategy in an everyday listening program during study

Ear to be Implanted:

  • Severe-to-profound sensorineural hearing loss (> 70 dB HL) as defined by the pure tone average for 500, 1000, 2000 and 4000 Hz
  • CNC word recognition score ≤30% (tested in subject's everyday listening condition for that ear)
  • Duration of severe-to-profound sensorineural hearing loss (≥ 70 dB HL) >3 months and ≤10 years in the ear to be implanted only

Contralateral (non-implanted) ear:

  • Up to a moderate sensorineural hearing loss (<70 dB HL) as defined by the pure tone average for 500, 1000, 2000 and 4000 Hz
  • CNC word recognition score >30% (tested in subject's everyday listening condition for that ear)

Exclusion criteria

  • Previous experience with a cochlear implant
  • Cochlear malformation or obstruction (i.e. ossification) that would preclude full insertion of electrode array in the ear to be implanted
  • Medical or psychological conditions that contraindicate surgery or impact the ability to manage an implanted device or the study related procedures as determined by the investigator
  • Diagnosis of auditory neuropathy/dys-synchrony in either the ear to be implanted or the contralateral ear
  • Active middle-ear disease/infection in the ear to be implanted
  • Unrealistic expectations regarding potential benefits, risks and limitations inherent to implant surgical procedures as determined by the investigator
  • Unwillingness or inability of subject to comply with all investigational requirements as determined by the investigator

Treatment and study plan

HiResolution Bionic Cochlear Implant

Device

HiRes 90K™ Advantage implant with HiFocus™ 1J electrode, HiRes 90K™ Advantage implant with the HiFocus Helix™ electrode, HiRes 90K™ Advantage implant with the HiFocus™ Mid-Scala electrode or the HiRes™ Ultra Implant with the HiFocus™ Mid-Scala electrode will be implanted in adults with eligible hearing profile.

Primary outcomes

  1. Change in Consonant Nucleus-Consonant (CNC) Word Recognition Test (Implanted Ear Only)

    Time frame: Baseline and Twelve months

    The post-implant CNC word scores were compared to preimplant word scores. The CNC monosyllabic word test is a validated test of open-set word recognition ability. The test was administered in quiet at 60 target 0° azimuth) and scored as total number of words correct which is expressed for results/reporting as percentage correct. The CNC word test was the primary speech perception metric used for study inclusion determination and postoperative outcome comparison at defined intervals for this feasibility study. A higher percentage of recognized words represents better hearing of spoken words. The intent is to understand the benefit of the implant treatment option and restoration of auditory input results in improved speech understanding.

  2. Change in Unaided Hearing Thresholds (Contralateral, Non-Implanted Ear, Only)

    Time frame: Baseline and Twelve months

    Unaided audiometric thresholds compared to preimplant. Standard audiometric procedures were used for the testing of inter-octave frequencies as necessary.

    • Unaided air conduction thresholds using insert earphones at octave frequencies were measured for the contralateral, non-implanted ear at 250, 500, 1000, 2000, 4000 and 8000 Hz. Clinical masking was completed as appropriate.

  3. Change in Speech Perception (Bilateral Listening Condition) - Speech Front, Noise Front

    Time frame: Baseline and Twelve months

    AzBio speech scores in speech front, noise front twelve months post implantation compared to preimplant bilateral sentence scores. The AzBio speech testing was the primary speech perception metric used for baseline and postoperative outcome comparison at defined intervals for this feasibility study. A higher percentage of recognized words represents better hearing of spoken words.

  4. Change in Lateralization Ability Testing (Bilateral Listening Condition)

    Time frame: Baseline and Twelve months

    Lateralization is ability to recognize the location of sound origin compared to preimplantation. The subject was asked to identify if the sentence was heard from the right or left loudspeaker. Scoring was based on the number of sentence locations correctly identified and expressed as a percent average. A higher percent average indicates a better ability to identify sound location.

  5. Change in Speech Perception (Bilateral Listening Condition) - Speech Front/Noise to Implanted Ear

    Time frame: Baseline to Twelve Months

    AzBio word scores in speech front, noise to implanted ear twelve months post implantation compared to preimplant bilateral sentence scores. The AzBio speech testing was a speech perception metric used for baseline and postoperative outcome comparison at defined intervals for this feasibility study. A higher percentage of recognized words represents better hearing of spoken words.

  6. Bilateral Listening Condition (Both Ears - Everyday Listening Condition for Each Ear) - Speech Front /Noise to Non-Implanted Ear.

    Time frame: Baseline to Twelve Months

    AzBio speech scores in speech front, noise to the contralateral ear at 12 months post implantation compared to preimplant bilateral sentence scores. The baseline speech perception testing was a speech perception metric used for baseline and postoperative outcome comparison at defined intervals for this feasibility study. A higher percentage of recognized words represents better hearing of spoken words.

Sponsors and collaborators

Lead sponsor

Advanced Bionics

Industry

Registry information

Important dates

Study start
2016
Primary completion
2020
Study completion
2020
First posted
Jun 23, 2016
Registry last updated
Aug 21, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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