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Multicenter US Clinical Trial With an Electric-Acoustic Stimulation (EAS) System in Adults: Final Outcomes
Harold C Pillsbury1, Margaret T Dillon1, Craig A Buchman1
1Department of Otolaryngology/Head and Neck Surgery, University of North Carolina School of Medicine, Chapel Hill, North Carolina.
Summary
The MED-EL Electric-Acoustic Stimulation (EAS) System safely and effectively improved speech perception for adults with low-frequency residual hearing and severe-to-profound high-frequency hearing loss. Most participants showed significant gains, demonstrating the system
Area of Science:
- Otorhinolaryngology
- Audiology
- Biomedical Engineering
Background:
- Many adults experience residual low-frequency hearing with severe-to-profound high-frequency sensorineural hearing loss.
- Traditional hearing aids may not provide sufficient benefit for this patient population.
- Electric-Acoustic Stimulation (EAS) offers a combined approach of electric stimulation and acoustic amplification.
Purpose of the Study:
- To evaluate the safety and effectiveness of the MED-EL EAS System.
- To assess outcomes in adults with residual low-frequency hearing and severe-to-profound mid-to-high frequency hearing loss.
Main Methods:
- Prospective, multicenter study involving 73 adult subjects implanted with MED-EL PULSAR or SONATA cochlear implants and FLEX electrode arrays.
- Subjects were fitted with an audio processor combining electric stimulation and acoustic amplification postoperatively.
- Hearing thresholds and speech perception (using City University of New York sentences and consonant-nucleus-consonant words) were assessed at 3, 6, and 12 months postactivation.
Main Results:
- 92% of subjects completed all study intervals; 79% maintained low-frequency hearing thresholds within 30 dB HL.
- 97% could use the acoustic component at 12 months.
- In the EAS condition, 94% performed similarly or better on speech-in-noise tests, with 85% showing improvement; 97% improved on word recognition tests, with 84% demonstrating improvement.
Conclusions:
- The MED-EL EAS System is a safe and effective treatment for adults with specific patterns of hearing loss.
- This technology provides significant speech perception benefits for individuals not adequately served by conventional amplification.
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