Comparing cochlear implant fitting methods for better outcomes

Anatomy-based Fitting in Unexperienced Cochlear Implant Users. Programación Basada en la anatomía en Usuarios Nuevos de Implante Coclear.

This study is testing which cochlear implant fitting method works better for new users by comparing standard fitting, anatomy-based fitting, and a mix of both.

Quick facts

• Phase: NA
• Study type: Interventional
• Enrollment: 30 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Fundacion para la Investigacion Biomedica del Hospital Universitario la Paz (other)
• Locations: 1 site (Madrid, Madrid)
• Trial ID: NCT05360212 on ClinicalTrials.gov

What this trial studies

This study investigates the performance of cochlear implants (CIs) in newly implanted users by comparing two fitting methods: standard frequency-band distribution and anatomy-based fitting. Participants will be divided into three groups, with one group using standard fitting, another using anatomy-based fitting, and a third group alternating between both methods weekly. The aim is to assess which fitting method leads to better auditory outcomes over time. The study will utilize the MAESTRO 9 system for both fitting approaches.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18 and older with severe to profound sensory-neural hearing loss who are receiving a MED-EL cochlear implant.

Not a fit: Patients who do not meet the eligibility criteria, such as those with different types of hearing loss or those not fluent in Spanish, may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could lead to improved auditory outcomes and quality of life for cochlear implant users.

How similar studies have performed: While there have been studies on cochlear implant fitting methods, this specific approach of anatomy-based fitting is relatively novel and has not been extensively tested.

Eligibility criteria

Inclusion Criteria:

* Age ≥ 18 years
* 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 or FlexSoft electrode
* Subject planned to receive a SONNET 2 /RONDO3 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 Spanish
* Signed and dated ICF before the start of any study-specific procedure

Specific inclusion criteria for the possible study groups • Bilateral CI users: Bilateral CI implantation SONNET 2/RONDO3 audio processor on the first ear implanted

* 40% speech recognition a monosyllabic word Test in quiet at 65 dB SPL (last time tested) on the already implanted side
* 40% speech recognition in a sentence test in noise (10 dB SNR) on the already implanted side First activation of the already implanted side between 3 and 12 months prior to study inclusion

  • Unilateral CI users: Unilateral CI implantation CI user with contralateral hearing ≥ 60 dB (PTA measured at 500, 1000, 2000, and 4000 Hz)

  • SSD CI users: Unilateral CI implantation CI user with contralateral hearing ≤30 dB (PTA measured at 500, 1000, 2000, and 4000 Hz) Interaural threshold gap ≥40 dB

  • Bimodal CI users: Unilateral CI implantation Contralateral ear adequately fitted with a hearing aid CI user with contralateral hearing ≥30 dB (PTA measured at 500, 1000, 2000, and 4000 Hz) CI user with contralateral hearing ≤55 dB (PTA measured at 500, 1000, 2000, and 4000 Hz) Interaural threshold gap ≥15 dB

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
* Known allergic reactions to components of the investigational medical device
* 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

Where this trial is running

Madrid, Madrid

• Hospital Universitario de La Paz — Madrid, Madrid, Spain (RECRUITING)

Study contacts

• Principal investigator: Luis Lassaletta, PhD — Fundacion para la Investigacion Biomedica del Hospital Universitario la Paz
• Study coordinator: Luis Lassaletta, PhD

Conditions: Cochlear Implant, Outcomes, Quality of Life