# FDA EIR - Cochlear Americas Inc. - February 22, 2018

Source: https://www.keypedia.com/records/eir/cochlear-americas-inc/513d3fd5-762c-4ed8-9f96-cdc020214105

> FDA EIR for Cochlear Americas Inc. on February 22, 2018. Product: devices. Access full analysis and detailed observations.

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## Details

- Record Type: EIR
- Company Name: Cochlear Americas Inc.
- Inspection Date: 2018-02-22
- Product Type: devices
- Office Name: Denver District Office
- Summary: Cochlear Americas Inc. underwent a routine FDA inspection from February 2 to February 22, 2018, under the regulatory framework for Sponsors, Contract Research Organizations, and Monitors (CP 7348.810). The inspection focused on the company's oversight of the "Safety and Efficacy of the Cochlear Nucleus CI422 Cochlear Implant" study. An FDA Form 483 was issued, detailing significant observations. A primary violation (21 CFR 812.46(a)) was the company's failure to ensure investigators complied with study agreements and regulatory requirements. Specifically, informed consent forms used at several investigational sites were modified inconsistently, omitting crucial warnings, precautions for the cochlear implant, and statements regarding the clinical trial registry. Some forms also contained unsubstantiated risk percentages. Further issues included inaccurate and incomplete records for anticipated adverse device effects, with at least one serious adverse event not being reported by the sponsor. The company also failed to ensure proper monitoring of the investigational study and consistent Institutional Review Board (IRB) review and approval across all participating sites. Deficiencies in staff training for monitoring activities and missing essential site documentation were also noted. The regulatory implications for Cochlear Americas included potential Warning Letters and the risk of data rejection. This necessitates comprehensive corrective actions such as retraining clinical staff on adverse event reporting, protocol compliance, and informed consent procedures, along with revising operational procedures and enhancing internal reporting and oversight mechanisms for clinical trial sites.

## Related Documents

- [EIR - 2018-02-22](https://www.keypedia.com/records/eir/cochlear-americas-inc/7c978599-7af7-46eb-89c2-7ddacfb85aa3)
- [483 - 2018-02-22](https://www.keypedia.com/records/483/cochlear-americas-inc/e1d96993-d0f1-4a88-8746-4266a4878897)
- [483 - 2021-10-21](https://www.keypedia.com/records/483/cochlear-americas-inc/097e786d-e3b6-40a3-b4ff-93e96aba01a8)

## Related Officers

- [Theressa B. Smith](https://www.keypedia.com/people/theressa-b-smith/80f0c339-7eac-4c73-b9f6-ecb368738fe6)

Company: https://www.keypedia.com/companies/cochlear-americas-inc/87342f6e-3f58-4bea-b41f-0ab2088226df

Office: https://www.keypedia.com/offices/denver-district-office/93b79063-390c-4759-af6c-5da7e388face