Influence of Anatomy Based Frequency Mapping on Speech Outcomes and Hearing Related Measures
Conditions
Brief summary
The present study investigates CI users' potential differences in speech tests, other performance measures (i.e. pitch-matching, perception of timbre and melodic intervals, consonance perception), and patient-reported outcome (i.e. questionnaires) between the clinical fitting map and anatomy-based fitting in two groups of CI users (one with standard fitting and one with anatomy-based fitting).
Interventions
OTHERfrequency distribution type
One group is fitted using channel filterbank frequency distribution based on anatomy data extracted from post-OP CT measurements. The second (control) group is fitted with the standard frequency distribution used in MAESTRO 9 fitting software.
Sponsors
Dominik Riss
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
BASIC_SCIENCE
Masking
DOUBLE (Subject, Investigator)
Masking description
double blinded design: both the participant and the investigator have no information about the treatment group.
Intervention model description
The performance with the CI is investigated over time in two groups of freshly implanted CI users. The first group is fitted using the standard frequency-band distribution as implemented in MAESTRO 9 fitting software. In the second group of users, an anatomy-based frequency distribution is used as per anatomy-based fitting in MAESTRO 9.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Post-lingual onset of severe to profound sensory-neural hearing loss in the implanted ear(s) * Post-OP CT scan of the CI electrode available * Subject implanted with MED-EL cochlear implant(s) * Subjects received a Flex28, FlexSoft and Standard electrode * Subject planned to receive a SONNET 2 or RONDO 3 audio processor on the newly implanted side * Audio processor not yet activated on the newly implanted side * The most apical active electrode contact has to be inserted at least 450° * Minimum of 10 active channels can be activated * Fluent in the language of the test centre * Signed and dated ICF before the start of any study-specific procedure
Exclusion criteria
* Lack of compliance with any inclusion criteria * EAS user (user of an EAS audio processor) * Implanted with C40+, C40X and C40C * Implanted with an ABI or Split electrode array * Anything that, in the opinion of the Investigator, would place the subject at increased risk or preclude the subject's full compliance with or completion of the study
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Word recognition score (WRS) | 6 months | Percentage of correctly understood monosyllabic words from a list. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Speech reception threshold (SRT) | 6 months | German matrix sentence test - speech to noise ratio in dB. |
| Pitch ranking | 6 months | Difference of the mean ranks for a set of frequencies presented to the tested CI ear and the reference ear. |
| Perception of timbre | 6 months | Visual Analog Scale ratings describing the difference in timbre between the tested CI ear and the reference ear when listening to audio. |
| Phoneme categorization | 6 months | Shape of the psychometric function describing the perception of the /s/-/ʃ/ continuum. |
| Consonance/difference rating | 6 months | The degree of modulation of the pleasantness-score across the individual intervals. |
Countries
Austria
Contacts
Primary ContactDominik Riss, MD
Outcome results
None listed