Comparison of the New Fitting Method Cochlear Nucleus Fitting Software (NFS) With the Established Fitting Method Cochlear Nucleus Custom SoundTM Suite (CSS)

Cochlear48 enrolled

Overview

The purpose of this study is to evaluate if the new and simplified fitting method with Cochlear Nucleus Fitting Software (a major component of a suite of tools which form the Clinical Care Innovation) provides Cochlear Implants Recipients with the same hearing outcome as the current and established clinical fitting method with Cochlear Nucleus Custom SoundTM Suite. The Clinical Care Innovation method reduces fitting to simple volume, bass and trebles adjustments, operations which are familiar to anyone who has used an audio player.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

SUPPORTIVE_CARE

Masking

DOUBLE

Enrollment

Conditions

Hearing Loss

Interventions

NFS

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Newly implanted subjects with available Nucleus Cochlear Implants compatible with CP900 series sound processors (excluding Cochlear Nucleus Hybrid) * Post linguistically deafened adults (≥ 18 years) * Unilaterally implanted * ≤ 15 years of severe to profound deafness prior to implantation * Subjects who are capable and willing to participate in speech perception tests in local language * Subjects who are able to provide feedback in form of a written questionnaire (e.g. Speech Spatial Hearing Qualities questionnaire) * Subjects willing to give their consent to the study Exclusion Criteria: * Additional handicaps that would prevent participation in evaluations (e.g. visual impairment, blindness) * Unrealistic expectations on the part of the subject, regarding the possible benefits, risks and limitations that are inherent to the procedure/fitting method * Bilateral implantation * Hybrid-L (not supported by Nucleus Fitting Software) * Subjects who already have hearing experience with a Cochlear Implant (e.g. reimplantation, contralateral Cochlear Implant) * Subjects with single-sided deafness * Known cochlea malformations * Subjects who lost their hearing due to meningitis

Locations (3)

Deutsches HörZentrum Hannover der HNO-Klinik der MHH

Hanover, Lower Saxony, Germany

Universitätsklinikum Schleswig-Holstein - Campus Kiel, Klinik für Hals, Nasen-, Ohrenheilkunde, Kopf und Halschirurgie

Kiel, Schleswig-Holstein, Germany

Department of Otorhinolaryngology, Head and Neck Surgery, University Hospital

Zurich, Canton of Zurich, Switzerland

Outcomes

Primary Outcomes

Speech perception performance in subjects fitted with Nucleus Fitting Software and subjects fitted with Nucleus Custom SoundTM Suite assessed via aided hearing thresholds

Adaptive Oldenburg Sentence Test in noise with speech at 65 dB (if the subject's understanding with Oldenburg Sentence Test in quiet is ≥ 70%).

Time frame: 3 months after implantation

Speech perception performance in subjects fitted with Nucleus Fitting Software and subjects fitted with Nucleus Custom SoundTM Suite assessed via aided hearing thresholds

Adaptive Oldenburg Sentence Test in noise with speech at 65 dB (if the subject's understanding with Oldenburg Sentence Test in quiet is ≥ 70%).

Time frame: 6 months after implantation

Speech perception performance in subjects fitted with Nucleus Fitting Software and subjects fitted with Nucleus Custom SoundTM Suite assessed via aided hearing thresholds

Adaptive Oldenburg Sentence Test in noise with speech at 65 dB (if the subject's understanding with Oldenburg Sentence Test in quiet is ≥ 70%).

Time frame: 9 months after implantation

Speech perception performance in subjects fitted with Nucleus Fitting Software and subjects fitted with Nucleus Custom SoundTM Suite assessed via aided hearing thresholds

Adaptive Oldenburg Sentence Test in noise with speech at 65 dB (if the subject's understanding with Oldenburg Sentence Test in quiet is ≥ 70%).

Time frame: 12 months after implantation

Speech perception performance in subjects fitted with Nucleus Fitting Software and subjects fitted with Nucleus Custom SoundTM Suite assessed via aided hearing thresholds

Adaptive Oldenburg Sentence Test in noise with speech at 65 dB (if the subject's understanding with Oldenburg Sentence Test in quiet is ≥ 70%).

Time frame: 15 months after implantation