Clinical Research Directory

Effects of Binaural Hearing on Listening Effort and Cognitive Development in Mandarin-speaking Children With Cochlear Implants

This 5-year (2025-2030) prospective observational cohort study aims to recruit 360 participants aged 6-18 years, categorized into three groups: normal-hearing controls, unilateral listeners (unilateral cochlear implantation), and bilateral listeners (bilateral cochlear implantation or bimodal stimulation). At baseline, all participants will undergo comprehensive evaluations, including audiological testing (speech recognition and spectral/temporal resolution), cognitive assessment (WISC and prefrontal resting-state functional connectivity), and social adaptability measurement. Centrally, listening effort will be quantified through an innovative multimodal approach that synchronously records pupil diameter changes and cortical hemodynamic signals via functional near-infrared spectroscopy (fNIRS) during tasks of varying difficulty, objectively reflecting the cognitive resources exerted for speech processing. Through a 3-year longitudinal follow-up, this study seeks to elucidate how different auditory input modes influence children's listening effort, cognitive development, and social adaptation, ultimately providing a robust scientific foundation for optimizing clinical rehabilitation strategies.

Investigating the Acceptance and Performance of Low Energy Audio Streaming in Nucleus 8 and Kanso 3 Sound Processors by Experienced Cochlear Implant Users

This study aims to investigate acceptance and performance of the Bluetooth Low Energy Audio-enabled (LE Audio) firmware in the Nucleus 8 Processing Unit, Kanso 3 Nexa Sound Processor, and the Kanso 3 Sound Processor. The investigation includes actual use (take home) of LE Audio firmware releases and the new GN ReSound LE Audio wireless accessories, including the Multi-Mic+, for use in the real-world. Using the final versions of firmware, speech perception performance in noise will be investigated using the Nucleus 8 and Kanso 3 Sound Processors streaming via a Multi-Mic+.

Assessment of a Method to Improve Cochlear Implant Users' Speech Perception in Noisy Environments While Maintaining Their Ability to Determine Where a Sound Originates From

The goal of this clinical trial is to determine if a new algorithm can improve speech perception for cochlear implant users. The main questions it aims to answer \[is/are\]: * Does the algorithm improve speech perception in noisy environments? * Does the algorithm allow listeners to determine where a sound is coming from? Participants will * Listen to and repeat sentences presented in the presence of noise * Indicate the location that sounds originated from

Cochlear Implants and Listening Effort: the Interaction of Cognitive and Sensory Constraints

This study examines how cochlear implant users understand and comprehend speech in realistic communication situations. Through six experiments measuring listening effort via pupillometry and discourse comprehension, we will investigate how linguistic context, cognitive demands, and processing time affect speech understanding in CI users, and in normal-hearing controls) to identify factors underlying communication resilience versus vulnerability and develop improved, ecologically valid assessment and rehabilitation strategies.

This Clinical Investigation Assesses the Safety and Performance of a New Beamformer for MED-EL Cochlear Implant Recipients.

Cochlear implants help individuals with hearing loss by delivering electrical signals directly to the auditory nerve, bypassing damaged parts of the ear. While they significantly improve speech perception in quiet environments and over the telephone, challenges remain in noisy environments due to interference from background noise. To address this, advancements in signal-processing strategies, microphone technology, and noise-reduction algorithms have been introduced. The focus of the study is on two new front-end features: * Focused Beamformer - Enhances directional hearing. * AI Mode Medium - Utilizes the adaptive intelligence for optimized sound processing.

Early Cochlear Implant Use

This observational study will examine newly activated cochlear implant users and determine whether their abilities to discern simple sounds change and relate to improved speech perception. Take-home computers and test-equipment will be sent home, and subjects will complete approximately 25 test sessions over the first 3 months of cochlea implant use. Then, subjects will be tested 3 more times in the laboratory until 1 year-post activation. The primary objective is to determine and quantify how sounds change and speech perception improves over the course of early cochlear implant use.