Developing Wearable Headband for Enhancing Slow Wave Sleep in Alzheimer's Patients; Investigating Normalizing Bias in Cochlear Implant Regulations

Radadiya, Devanshi, School of Engineering and Applied Science, University of Virginia
Forelle, MC, EN-Engineering and Society, University of Virginia
Fitzgerald, Gerard, EN-Engineering and Society, University of Virginia
Allen, Timothy, EN-Biomed Engr Dept, University of Virginia
Shumway, Spencer, Sequoia Neurovitality LLC
Blair, Joshua, Sequoia Neurovitality LLC
Orellana, Stefany, Sequoia Neurovitality LLC

This paper explores the various complexities surrounding normalizing biases in the regulation of cochlear implants (CIs). Cochlear implants (CIs) are devices that are surgically installed into a region above the ear to stimulate the auditory nerve and allow for pseudo-hearing. Although CIs are classified as assistive devices, they are not fully accepted by those within the deaf community as they assume that being deaf is a disability that needs to be fixed. Moreover, these devices are difficult to access based on various social factors such as race, age, and socioeconomic status. The development of CIs is contextualized first with a historical overview that outlines these intersections of changing perceptions of deafness and disability with advancements in technology. Primarily, this paper argues that the aforementioned biases are not incidental, but are embedded within the technological and regulatory parameters that affect CI deployment. In order to identify the root of these biases, a literature review was conducted of relevant regulatory materials surrounding CIs. The Food and Drug Administration (FDA) regulatory guidelines for Class III medical devices and the eligibility criteria for CI recipients were examined to reveal how these regulatory frameworks reflect broader societal biases that favor hearing norms and marginalize deaf communities. Moreover, premarket approvals (PMAs) and special exemption pathways were analyzed as they pertain to CIs to highlight similar gaps. These regulations were examined from the perspective of care ethics in order to analyze how these regulations tie into the ethical dimensions of CIs, which may be responsible for the emphasis on 'fixing' deafness through technology. The literature review yielded results which indicated that the role of regulatory bodies in overlooking the cultural and linguistic richness of deaf communities, framing deafness primarily as a deficiency to be corrected. Key findings included that current regulations point to a “one size fits all” approach to CI administration, as CIs are not required to be tested for use based on racial differences during clinical trials. Moreover, clinical trials may be circumvented entirely via 510k submissions and PMAs, and are rarely tested on pediatric patients despite doctor recommendations that CIs be implanted at as early of an age as possible. These findings point towards the idea that the current regulations fail to provide holistic treatment to the diverse array of patients that they aim to treat. Accounting for these gaps, care ethics calls for a revision of these regulations in order to reflect a broader understanding of deafness, as well as increase informed consent processes, and promote partnerships with deaf communities to provide more equitable approaches to CI use.

BS (Bachelor of Science)
Cochlear Implant, Deafness, FDA Regulations, Care Ethics, Medical Devices, Alzheimer's Disease

School of Engineering and Applied Science

Bachelor of Science in Biomedical Engineering

Technical Advisor: Joshua Blair, Stefany Orellana, Spencer Shumway, Dr. Timothy Allen

STS Advisor: Dr. MC Forelle, Dr. Gerard Fitzgerald

Technical Team Members: Josiah Calhoun, Hannah Park, Justin Tran, Keerthana Vijayaragavan

Issued Date: