U.S. Phase I preliminary results of use of the Otologics MET Fully-Implantable Ossicular Stimulator

Herman A. Jenkins, James S. Atkins, Drew Horlbeck, Michael E Hoffer, Ben Balough, Joseph V. Arigo, George Alexiades, William Garvis

Research output: Contribution to journalArticle

42 Citations (Scopus)

Abstract

Objectives: The safety of the Otologics Fully-Implantable MET Ossicular Stimulator was assessed in adult patients with bilateral moderate to severe sensorineural hearing loss. Methods: Surgical implantation of the ossicular stimulator was performed. A repeated-measure, within-subjects design assessed safety and aided sound field thresholds and speech performances with the subject's own, appropriately fitted, walk-in hearing aid(s) and the Otologics Fully-Implantable MET Ossicular Stimulator. Results: Twenty patients were implanted and activated as part of the Phase I clinical trial. Results demonstrated 10-20 dB of functional gain across audiometric frequencies. Pure tone averages and monaural word recognition scores were slightly better for the walk-in-aided condition, while patient benefit scales favored the postoperative implant-aided conditions. Conclusion/Significance: Although monaural word scores and aided thresholds favored the walk-in-aided condition, preliminary results indicate that the Otologics MET Fully-Implantable Ossicular Stimulator is an alternative to currently available hearing aids in patients with sensorineural hearing loss.

Original languageEnglish (US)
Pages (from-to)206-212
Number of pages7
JournalOtolaryngology - Head and Neck Surgery
Volume137
Issue number2
DOIs
StatePublished - Aug 2007
Externally publishedYes

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Hearing Aids
Sensorineural Hearing Loss
Safety
Clinical Trials, Phase I

ASJC Scopus subject areas

  • Otorhinolaryngology

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U.S. Phase I preliminary results of use of the Otologics MET Fully-Implantable Ossicular Stimulator. / Jenkins, Herman A.; Atkins, James S.; Horlbeck, Drew; Hoffer, Michael E; Balough, Ben; Arigo, Joseph V.; Alexiades, George; Garvis, William.

In: Otolaryngology - Head and Neck Surgery, Vol. 137, No. 2, 08.2007, p. 206-212.

Research output: Contribution to journalArticle

Jenkins, Herman A. ; Atkins, James S. ; Horlbeck, Drew ; Hoffer, Michael E ; Balough, Ben ; Arigo, Joseph V. ; Alexiades, George ; Garvis, William. / U.S. Phase I preliminary results of use of the Otologics MET Fully-Implantable Ossicular Stimulator. In: Otolaryngology - Head and Neck Surgery. 2007 ; Vol. 137, No. 2. pp. 206-212.
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