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Envoy Medical reports 12-month CNC gains for Acclaim fully implanted CI

Jul 14, 2026, 9:19 AM EDT1 sourcesAI-analyzed

Why it may matterVerify against the original reporting

Positive interim efficacy with no SAEs can raise optimism around the Acclaim CI's regulatory path; combined with Stage 2 enrollment and near-term PMA timing, it may support a multi-quarter price uplift, subject to confirming Stage 2 results and FDA feedback.

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What happened, with direct paths to the underlying reporting

Envoy Medical reports Stage 1 Acclaim CI 12-month data: CNC mean 53.2% versus 15.2% baseline, a 38-point gain. Nine of ten participants showed a positive response; no SAEs were reported. Stage 2 is fully enrolled, with 12-month data expected by early 2027 and a PMA submission planned shortly after.

Stage 1 CNC at 12 months reached 53.2% vs 15.2% baseline.
38.0 percentage-point gain; improvement continues from 6-month data.
Nine of ten participants showed positive hearing; one non-responder reviewed.
No SAEs reported through 12 months in Stage 1.
Stage 2 fully enrolled; 12-month data expected by early 2027.

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