The brief

Analyst view

• Esteem is the only FDA-approved fully implanted hearing device (since 2010) for moderate-to-severe loss.
• Acclaim, first fully implanted CI, completed pivotal trial enrollment in Apr 2026 with all 56 patients activated.
• Acclaim received FDA Breakthrough Device Designation in 2020; PMA filing expected after 12-month follow-ups.

Technical approach

As reported

Esteem implant

Active middle ear vibration

Implanted device mechanically vibrates middle ear bones for patients with moderate-to-severe loss.

Acclaim sensor

Sensor-based sound capture

Unlike CI with external mics, Acclaim uses a sensor that captures vibrations from the ear's natural anatomy.

Surgical placement

Implanted architecture

Both devices implant in the middle ear via outpatient surgery, requiring no external processors.

Signal processing

Intelligent conversion

Implanted processor converts audio signals and delivers them directly to hearing structures.

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