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

Hearing Loss Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02811549
• Other study ID #: CR0314
• Status: Completed
• Phase: N/A
• Start date: November 7, 2016
• Est. completion date: March 25, 2020

Study information

• Verified date: July 2023
• Source: Advanced Bionics
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 24
• Est. completion date: March 25, 2020
• Est. primary completion date: March 25, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

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

Intervention

Device:
• HiResolution Bionic Cochlear Implant
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.

Locations

Country	Name	City	State
United States	The Silverstein Institute	Sarasota	Florida
United States	Virginia Mason Medical Center	Seattle	Washington

Sponsors (1)

Lead Sponsor	Collaborator
Advanced Bionics

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in Consonant Nucleus-Consonant (CNC) Word Recognition Test (Implanted Ear Only)	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.	Baseline and Twelve months
Primary	Change in Unaided Hearing Thresholds (Contralateral, Non-Implanted Ear, Only)	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.	Baseline and Twelve months
Primary	Change in Speech Perception (Bilateral Listening Condition) - Speech Front, Noise Front	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.	Baseline and Twelve months
Primary	Change in Lateralization Ability Testing (Bilateral Listening Condition)	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.	Baseline and Twelve months
Primary	Change in Speech Perception (Bilateral Listening Condition) - Speech Front/Noise to Implanted Ear	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.	Baseline to Twelve Months
Primary	Bilateral Listening Condition (Both Ears - Everyday Listening Condition for Each Ear) - Speech Front /Noise to Non-Implanted Ear.	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.	Baseline to Twelve Months