Adverse Event Trends in Cochlear Implants: An Analysis From the MAUDE Database
Author(s)
Crispin D. J, PharmD1, Adusumilli Pramod Kumar, Ph.D2, Sannidhi Prabhu, PharmD3.
1Student, M S Ramaiah University Of Applied Sciences, Bengaluru, India, 2M S Ramaiah University Of Applied Sciences, Bangalore, India, 3M S Ramaiah University Of Applied Sciences, Bengaluru, India.
1Student, M S Ramaiah University Of Applied Sciences, Bengaluru, India, 2M S Ramaiah University Of Applied Sciences, Bangalore, India, 3M S Ramaiah University Of Applied Sciences, Bengaluru, India.
OBJECTIVES: The objective of this study is to analyze adverse event reports related to cochlear implants, which are classified as Class III high-risk medical devices, from the FDA’s MAUDE (Manufacturer and User Facility Device Experience) database. It aims to identify the nature and frequency of complications, evaluate device-related issues, and assess patient safety profiles. The findings will support the recognition of safety trends, improvement in implant design and manufacturing, and emphasizing the need for robust post-market surveillance to enhance patient outcomes and device safety.
METHODS: This review analyzes adverse events (AEs) related to cochlear implants reported in the MAUDE database from May 2023 to May 2025. Using specific search terms and filters, all relevant AE reports were retrieved and categorized based on significant variables and frequencies. The underlying causes and occurrence of AEs were examined to identify patterns and high-risk areas. This comprehensive evaluation provided valuable insights into the safety, performance, and potential areas of improvement for cochlear implants
RESULTS: An analysis of 500 adverse event reports related to cochlear implants for 2 years revealed that 63.6% cases were classified as injuries (318 cases), while 37% involved malfunctions (185 cases). The most frequent device issue was mechanical problems, comprising 123 cases, followed by impedance problems (83 cases) and expulsion (48 cases). Patient-related problems that are highly prevalent were headache (187 cases), followed by failure of implant (73 cases). Reports were predominantly from the U.S. The COCHLEAR LTD was identified as the manufacturer in 253 reports
CONCLUSIONS: Cochlear implants play a vital role in restoring hearing and improving quality of life for individuals with severe hearing loss. MAUDE data shows cochlear implants are generally safe, but risks persist. Continued monitoring, adherence to best practices, and patient education are essential until further studies clarify long-term outcomes and help improve implant safety and performance.
METHODS: This review analyzes adverse events (AEs) related to cochlear implants reported in the MAUDE database from May 2023 to May 2025. Using specific search terms and filters, all relevant AE reports were retrieved and categorized based on significant variables and frequencies. The underlying causes and occurrence of AEs were examined to identify patterns and high-risk areas. This comprehensive evaluation provided valuable insights into the safety, performance, and potential areas of improvement for cochlear implants
RESULTS: An analysis of 500 adverse event reports related to cochlear implants for 2 years revealed that 63.6% cases were classified as injuries (318 cases), while 37% involved malfunctions (185 cases). The most frequent device issue was mechanical problems, comprising 123 cases, followed by impedance problems (83 cases) and expulsion (48 cases). Patient-related problems that are highly prevalent were headache (187 cases), followed by failure of implant (73 cases). Reports were predominantly from the U.S. The COCHLEAR LTD was identified as the manufacturer in 253 reports
CONCLUSIONS: Cochlear implants play a vital role in restoring hearing and improving quality of life for individuals with severe hearing loss. MAUDE data shows cochlear implants are generally safe, but risks persist. Continued monitoring, adherence to best practices, and patient education are essential until further studies clarify long-term outcomes and help improve implant safety and performance.
Conference/Value in Health Info
2025-11, ISPOR Europe 2025, Glasgow, Scotland
Value in Health, Volume 28, Issue S2
Code
RWD10
Topic
Clinical Outcomes, Epidemiology & Public Health, Real World Data & Information Systems
Disease
Injury & Trauma, No Additional Disease & Conditions/Specialized Treatment Areas, Sensory System Disorders (Ear, Eye, Dental, Skin)