H90.1 Z96.2 Z46.2
Conditions
Interventions
Group 1: 1. Anatomy-based CI processor fitting based on postoperative imaging (photon-counting CT).
Group 2: 2. Pitch-based CI processor fitting based on a pitch comparison test with the normal-hearin
Sponsors
Unimedizin Frankfurt, KHNO, Audiologische Akustik
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: -SSD CI recipients, near normal hearing in the opposite ear (pure tone air conduction equal or less 30 dB HL 500 Hz - 1 kHz, equal or less 40 dB HL 2 - 8 kHz). -CI-processor programming allows setting of customized filter bank: support of individual frequency mapping is realized with Otoplan 4 and MAESTRO 9 / 10 / 11 (MED-EL, Innsbruck, Austria). Only patients provided with products of this manufacturer will be included. -Duration of deafness less than 15 years. -Sufficient proficiency of German language for speech perception tests. -Angle of insertion of the most apical electrode at least 540 degrees -Minimum number of active channels: 11 -MED-EL FLEX Electrodes, Synchrony 2 Implants, Flex 28 and Flexsoft electrodes, -CI-Processors: Sonnet 2, Sonnet 3 or Rondo 3. -No prior experience of PBF/ABF filter settings or participation in the 'INDICI' study. -Willingness to use PBF/ABF fitting on a daily basis during 2 accommodation interval.
Exclusion criteria
Exclusion criteria: -Congenital unilateral deafness or congenital unilateral profound hearing loss. -Partial insertion of CI-electrode: Cases with electrode tip foldover or other anomalous deviation of electrodeplacement are excluded. -CI-Non user (does not accept CI at all). -Compromised auditory nerve (e.g. patients post severe head trauma or severe meningitis). -Malformations of the cochlea. -Stimulation of the facial nerve.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Primary efficacy endpoints: Speech perception in noise depending on filter bank setting, differentiated according to summation, head shadow and squelch effect: Speech perception will be assessed with three filter bank settings: STD, PBF and ABF frequency mapping. Speech perception in noise is measured with the OLSA Matrix test. Speech level is set to 65 dB SPL. Noise level is set adaptively to measure speech reception threshold (SRT). Outcome variables are the speech reception threshold differences measured in three conditions: summation (SUM-SRT-DIFF), head shadow (HS-SRT-DIFF) and squelch (SQ-SRT-DIFF). The “OLNOISE” setting of the OLSA matrix test shall serve as noise signal to assure steep discrimination functions. For each filter bank setting, an SRT difference (SRT-DIFF) of more than 0.5 dB SNR is considered significant. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Sound localization in terms of 1) accuracy (RMS angular error), method described by Bandeira et al. (2018), clinical MAP, ABF and PBF MAP. 2. Subjective individual benefit, assessed by means of the SSQ-questionnaire assessed at the beginning of the study (clinical MAP) and end of the different trial periods (ABF and PBF MAP). 3. Preference rating comparing conditions clinical MAP, ABF and PBF MAP assessed at the end of the trial period. 4. Music listening pleasantness depending on filter bank setting (ABF, PBF and clinical MAP). | — |
Countries
Germany
Contacts
Public ContactMarten Geisen
Unimedizin Frankfurt, KHNO, Audiologische Akustik
Outcome results
None listed