Actively Recruiting
Anatomy-based Fitting in Unexperienced Cochlear Implant Users. Programación Basada en la anatomía en Usuarios Nuevos de Implante Coclear.
Led by Fundacion para la Investigacion Biomedica del Hospital Universitario la Paz · Updated on 2025-08-12
30
Participants Needed
1
Research Sites
13 weeks
Total Duration
On this page
Sponsors
F
Fundacion para la Investigacion Biomedica del Hospital Universitario la Paz
Lead Sponsor
M
MED-EL Elektromedizinische Geräte GesmbH
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are evaluating cochlear implant (CI) performance over time in three groups of newly implanted CI users. The study compares the standard frequency-band distribution fitting and an anatomy-based fitting method using the MAESTRO 9 software. This research aims to understand how anatomy-based fitting impacts hearing outcomes and quality of life in users, with the study sponsored by Fundacion para la Investigacion Biomedica del Hospital Universitario la Paz. Participants are divided into three groups: one fitted with the standard frequency-band distribution, another using anatomy-based frequency distribution aligned with individual electrode tonotopy, and a third group who will use both fittings alternately each week. The third group carries both study maps on their audio processor and switches weekly between the standard and anatomy-based fittings to compare their auditory performance. Throughout the study, participants undergo speech tests in noise and quiet at six months to measure hearing outcomes. Researchers also evaluate sound quality and quality of life in challenging situations. Participants will be monitored regularly, and assessments include speech recognition and subjective evaluations, with the total study duration depending on individual progress and protocol timing.
CONDITIONS
Brief Title
Anatomy-based Fitting in Cochear Implant Users
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 18 years or older
- Post-lingual onset of severe to profound sensorineural hearing loss in the implanted ear(s)
- Post-operative CT scan of the cochlear implant electrode available
- Implanted with MED-EL cochlear implant(s)
- Received a Flex28 or FlexSoft electrode
- Planned to receive a SONNET 2 or RONDO3 audio processor on the newly implanted side
- Audio processor not yet activated on the newly implanted side
- Most apical active electrode contact inserted at least 450 degrees
- Minimum of 10 active channels can be activated
- Fluent in Spanish
- Signed and dated informed consent form before any study procedures
- Bilateral CI users must have SONNET 2 or RONDO3 audio processor on the first implanted ear
- Bilateral CI users must have 40% speech recognition on monosyllabic word test in quiet at 65 dB SPL on the already implanted side
- Bilateral CI users must have 40% speech recognition in sentence test in noise (10 dB SNR) on the already implanted side
- Bilateral CI users had first activation of already implanted side between 3 and 12 months prior to study inclusion
- Unilateral CI users must have contralateral hearing threshold of 60 dB or better (PTA at 500, 1000, 2000, and 4000 Hz)
- Single-sided deafness CI users must have contralateral hearing threshold of 30 dB or better with interaural threshold gap of 40 dB or more
- Bimodal CI users must have contralateral ear fitted with hearing aid
- Bimodal CI users must have contralateral hearing threshold of 30 to 55 dB with interaural threshold gap of 15 dB or more
You will not qualify if you...
- Does not meet any inclusion criteria
- Use of an EAS audio processor
- Implanted with C40+, C40X, or C40C devices
- Implanted with an auditory brainstem implant (ABI) or split electrode array
- Known allergic reactions to device components
- Any condition that increases risk or prevents full compliance or completion of the study according to investigator's opinion
AI-Screening
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Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 6 months
Participants receive cochlear implant fitting using one of three methods: standard frequency-band distribution, anatomy-based frequency distribution, or alternating weekly between both fittings on their audio processor to assess performance differences.
Regular visits for performance assessment throughout 6 months
Trial Site Locations
Total: 1 location
1
Hospital Universitario de La Paz
Madrid, Madrid, Spain, 28046
Actively Recruiting
Research Team
L
Luis Lassaletta, PhD
M
Miryam Calvino, PhD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
OTHER
Number of Arms
3
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