Comparing cochlear implant fitting methods for better outcomes

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• 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
• Email: llasaletta@salud.madrid.org
• Phone: 0034656898265

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Anatomy-based fitting for single-sided deaf CI users

  This study tests whether anatomy-based fitting changes how well adults with single-sided deafness use a cochlear implant to understand speech in noise and to enjoy music.

  Recruiting University Hospital, Antwerp · Antwerp · NCT07703800

• Anatomy-Based Fitting for People with a Cochlear Implant and Hearing Aid

  This study tests whether an anatomy-based frequency distribution works better than the default one for adults with a cochlear implant and a contralateral hearing aid.

  Recruiting at 2 sites Universitair Ziekenhuis Brussel · Antwerp and 1 other locations · NCT07691853

• Binaural cue sensitivity with combined electric and acoustic hearing in children and adults

  This project will test whether children and adults with cochlear implants and preserved low-frequency hearing can use binaural hearing cues better when they have both electric and acoustic stimulation.

  Recruiting Hearts for Hearing · Oklahoma City, Oklahoma · NCT07356128

• Combining electric and acoustic hearing for better outcomes in children and adults

  This study tests if combining electric and acoustic hearing helps children and adults with cochlear implants understand speech better and hear sounds around them more clearly.

  Recruiting at 3 sites Hearts for Hearing · Edmond, Oklahoma and 3 other locations · NCT05923203

• Evaluating music and voice skills in cochlear implant users

  This study is testing how well kids and adults with cochlear implants enjoy and understand music compared to people with normal hearing.

  Recruiting Fundacion para la Investigacion Biomedica del Hospital Universitario la Paz · Madrid, Madrid · NCT05319678

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.