Evaluation of Hearing Preservation in Adults With Partial Low-Frequency Hearing Implanted With the HiFocus™ Mid-Scala Electrode

Sponsor

Advanced Bionics (Industry)

Overall Status

Terminated

CT.gov ID

NCT01959152

Collaborator

(none)

Enrollment

Locations

Arm

Duration (Months)

0.3

Patients Per Site

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The purpose of this study is to determine the feasibility of preserving low-frequency acoustic hearing in adults with a moderate degree of hearing loss in the low frequencies and severe-to-profound hearing loss in the mid-to-high frequencies who are implanted with the HiRes™ 90K Advantage implant with HiFocus™ Mid-Scala electrode.

Condition or Disease	Intervention/Treatment	Phase
Hearing Loss Deafness Hearing Disorders Ear Diseases Otorhinolaryngologic Diseases	Device: HiRes™ 90K Advantage implant with HiFocus™ Mid-Scala electrode	N/A

Study Design

Study Type:

Interventional

Actual Enrollment :

1 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

Evaluation of Hearing Preservation in Adults With Partial Low-Frequency Hearing Implanted With the HiFocus™ Mid-Scala Electrode

Study Start Date :

Oct 1, 2013

Actual Primary Completion Date :

Sep 1, 2014

Actual Study Completion Date :

Nov 1, 2014

Arms and Interventions

Arm	Intervention/Treatment
Experimental: HiRes90K™ Advantage Cochlear Implant HiRes90K™ Advantage implant with HiFocus™ Mid-Scala electrode will be implanted in adults with a moderate level of hearing loss in the low frequencies and severe-to-profound hearing loss in the mid-to-high frequencies.	Device: HiRes™ 90K Advantage implant with HiFocus™ Mid-Scala electrode

Arm

Intervention/Treatment

Experimental: HiRes90K™ Advantage Cochlear Implant

HiRes90K™ Advantage implant with HiFocus™ Mid-Scala electrode will be implanted in adults with a moderate level of hearing loss in the low frequencies and severe-to-profound hearing loss in the mid-to-high frequencies.

Device: HiRes™ 90K Advantage implant with HiFocus™ Mid-Scala electrode

Outcome Measures

Primary Outcome Measures

Low-frequency unaided acoustic hearing thresholds pre and post implantation with the HiFocus™ Mid-Scala electrode array [One month]
Unaided low-frequency acoustic hearing thresholds (under earphones) in the implanted ear one month after device activation will be compared to baseline (pre-implant) thresholds in the same ear for audiometric frequencies 125-1000Hz. Threshold changes from baseline will be calculated as: Complete preservation of hearing: threshold shift ≤ 15 dB Partial preservation of hearing: threshold shift ≥ 16 dB with measurable thresholds No preservation of hearing: no measurable thresholds at ≤ 80 dB HL

Secondary Outcome Measures

Word recognition in quiet pre and post implantation with the HiFocus™ Mid-Scala electrode array [One month]
Word recognition scores in quiet in the implanted ear one month after device activation compared to pre-implant score with a hearing aid

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

No previous cochlear implant experience
18 years of age or older
Up to a moderate sensorineural hearing loss in the low-to-mid frequencies (pure tone average ≤ 65 dB HL for 125, 250, 500, and 1000 Hz) and a severe-to-profound sensorineural hearing loss in the high frequencies (pure tone average ≥ 70 dB HL for 2,000, 4,000, and 8,000 Hz) in the ear to be implanted
Aided monosyllabic word score of 10-50% in the ear to be implanted
Up to a moderate sensorineural hearing loss in the low-to-mid frequencies (pure tone average ≤ 65 dB HL for 125, 250, 500, and 1000 Hz) and a severe-to-profound sensorineural hearing loss in the high frequencies (pure tone average ≥ 70 dB HL for 2,000, 4,000, and 8,000 Hz) in the contralateral (non-implanted) ear
English language proficiency
Willingness to participate in all scheduled procedures outlined in the protocol

Exclusion Criteria:

Previous inner ear surgery
Cochlear malformation or obstruction that would preclude full insertion of electrode array
Presence of additional disabilities that would prevent or interfere with participation in the required study procedures
Medical or psychological conditions that contraindicate surgery or impact the ability to manage an implanted device or the study-related procedures
Evidence of central auditory lesion or compromised auditory nerve

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Dalhousie University, Department of Surgery, Division of Otolaryngology	Halifax	Nova Scotia	Canada	B3H 2Y9
2	The Ottawa Hospital, Parkdale Clinic, Audiology Department	Ottawa	Ontario	Canada	K1Y 4E9
3	Sunnybrook Health Sciences Centre, Department of Otolaryngology - Head and Neck Surgery	Toronto	Ontario	Canada	M4N 3M5