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

Hearing Loss Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01959152
• Other study ID #: CR0513
• Status: Terminated
• Phase: N/A
• First received: October 8, 2013
• Last updated: May 20, 2015
• Start date: October 2013
• Est. completion date: November 2014

Study information

• Verified date: April 2015
• Source: Advanced Bionics
• Contact: n/a
• Is FDA regulated: No
• Health authority: Canada: Health Canada
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 1
• Est. completion date: November 2014
• Est. primary completion date: September 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Deafness
• Ear Diseases
• Hearing Disorders
• Hearing Loss
• Otorhinolaryngologic Diseases

Intervention

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

Locations

Country	Name	City	State
Canada	Dalhousie University, Department of Surgery, Division of Otolaryngology	Halifax	Nova Scotia
Canada	The Ottawa Hospital, Parkdale Clinic, Audiology Department	Ottawa	Ontario
Canada	Sunnybrook Health Sciences Centre, Department of Otolaryngology - Head and Neck Surgery	Toronto	Ontario

Sponsors (1)

Lead Sponsor	Collaborator
Advanced Bionics

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Low-frequency unaided acoustic hearing thresholds pre and post implantation with the HiFocus™ Mid-Scala electrode array	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	One month	Yes
Secondary	Word recognition in quiet pre and post implantation with the HiFocus™ Mid-Scala electrode array	Word recognition scores in quiet in the implanted ear one month after device activation compared to pre-implant score with a hearing aid	One month	No