Hearing Loss, Cochlear

The Microtable® Microstereotactic Frame and Drill Press and Associated Method for Cochlear Implantation consists of a patient-customized microstereotactic frame which targets the cochlea. The intended use of the device in this early feasibility study is to surgically access the cochlea, allowing placement of an intra-cochlear electrode array for cochlear implantation, thereby providing a less invasive surgical option than currently performed. Compared to traditional cochlear implantation (CI) surgery, the investigators hypothesize that the minimally invasive, image-guided approach may offer the following benefits: (1) shorter procedure time including shorter general anesthesia time, (2) less tissue removal potentially eliminating post-operative mastoid bone depression, decreased post-operative patient discomfort, and quicker wound healing, (3) better chance of preservation of taste secondary to preservation of the chorda tympani nerve, and (4) standardization of electrode placement potentially allowing more consistent placement within the scala tympani sub-compartment of the cochlea which has been shown to be associated with improved post-operative audiological performance. This early feasibility study will focus on the advantages of the new technology to the patient. Advantages to the healthcare delivery system will be examined during the pivotal study phase.

This study is designed to understand how different hearing-aid noise-reduction technologies affect a listener's ability to hear speech in noisy environments. Participants will listen to speech at several background-noise levels while trying different processing settings. By comparing performance across these conditions, the study aims to identify which types of noise reduction improve speech intelligibility the most. We expect that some noise-reduction strategies will help listeners understand speech better than others, especially in more difficult listening situations.

The purpose of the proposed study is to evaluate the continued safety of the iotaSOFT Insertion System when used by a surgeon to assist with inserting a CI electrode array in one ear per subject