Lessons learned from Apple's De Novo for the Hearing Aid Feature

Note: This is an audio summary of the deep dive case study published earlier on the Let’s Talk Risk! newsletter. We used Google’s NotebookLM¹ to create this brief overview using the following sources:

1. LTR: Case Study: A smart benefit-risk strategy for market entry via the De Novo pathway.

2. FDA: De Novo decision summary for DEN230081, Issued December 2023.

3. FDA: Factors to Consider When Making Benefit-Risk Determinations in Medical Device Premarket Approval and De Novo Classifications, Issued August 2019.

4. CDC: Hearing difficulties among adults, United States, 2019.

5. Apple: How to take a Hearing Test and turn on the Hearing Aid feature, YouTube, Accessed November 23, 2024.

Read the human-created deep dive case study here

Case study: A smart benefit-risk strategy for market entry via the De Novo pathway

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Disclaimers

1. We do not have any affiliation with Apple. This audio overview should not be considered an endorsement of Apple’s products, including the Hearing Aid Functionality (HAF).

2. All information presented is for educational purposes and should not be considered regulatory advice.

1. Google: NotebookLM, accessed November 23, 2024. NotebookLM does not use any other source of information except those specifically provided by the user. Therefore, it is less likely to “hallucinate” and distort the underlying facts to create a false narrative.