Eligibility Module

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Eligibility Module

The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.

Eligibility Module path is as follows:

Study -> Protocol Section -> Eligibility Module

Eligibility Module

Ignite Creation Date: 2025-12-24 @ 4:37 PM
Ignite Modification Date: 2025-12-24 @ 4:37 PM
NCT ID: NCT06218966
Eligibility Criteria: Inclusion Criteria: * Adults, 18 years of age or older at the time of implantation * Moderate to profound hearing loss in the low frequencies and severe to profound hearing * Loss in the high frequencies, bilaterally as defined by (see Figure 4A and B below for example audiogram information) * Low-frequency pure tone average (PTA - 250, 500, and 1000 Hz) greater than 40 dB * High-frequencies not better than 65 decibels (3000 Hz - 8000 Hz) * Sensorineural hearing loss, demonstrated by an air-bone gap of less than or equal to 10 dB * Limited benefit from appropriately fit hearing aids, defined by consonant-nucleus-consonant (CNC) word score in quiet of 60% or less in the ear to be implanted and 70% or less in the non-implanted ear * CNC word score in quiet of greater than or equal to 10% in the ear to be implanted * Fluent in English * No radiological contraindications * Ability to undergo general anesthesia * Appropriate motivation and expectation levels * Stated willingness to comply with all study procedures for the duration of the study * Able to perform subjective hearing tests * Able to fill out questionnaires Exclusion Criteria: * Age less than 18 years * Not willing to provide informed consent * Unable to perform subjective hearing tests * Unable to fill out questionnaires * Previous unsensitivity to the investigated drug * Unable to follow the protocol for any reasons * Evidence that hearing loss is retrocochlear in origin * Active middle ear infection * Skin or scalp condition precluding use of external audio processor * Suspected cognitive impairment or organic brain dysfunction * History of prior use of a hearing implant
Healthy Volunteers: False
Sex: ALL
Minimum Age: 18 Years
Study: NCT06218966
Study Brief:
Protocol Section: NCT06218966