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

A

Advanced Bionics

Status

Completed

Conditions

Hearing Disorders
Otorhinolaryngologic Diseases
Ear Diseases
Hearing Loss
Asymmetrical Hearing Loss
Single-Sided Deafness

Treatments

Device: HiResolution Bionic Cochlear Implant

Study type

Interventional

Funder types

Industry

Identifiers

Details and patient eligibility

About

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).

Enrollment

24 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

24 participants in 1 patient group

HiResolution Bionic Cochlear Implant
Experimental group
Description:
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 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).
Treatment:
Device: HiResolution Bionic Cochlear Implant

Trial documents
1

Trial contacts and locations

2

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Data sourced from clinicaltrials.gov

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