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      Temporal-Bone Measurements of the Maximum Equivalent Pressure Output and Maximum Stable Gain of a Light Driven Hearing System that Mechanically Stimulates the Umbo

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          Abstract

          Hypothesis

          That maximum equivalent pressure output (MEPO) and maximum stable gain (MSG) measurements demonstrate high output and high gain margins in a Light Driven Hearing System (Earlens).

          Background

          The non-surgical Earlens consists of a light-activated balanced-armature Tympanic Lens (Lens) to drive the middle ear through direct umbo contact. The Lens is driven and powered by encoded pulses of light. In comparison to conventional hearing aids, the Earlens is designed to provide higher levels of output over a broader frequency range and a significantly higher MSG with the MEPO providing an important fitting guideline.

          Methods

          Four fresh human cadaver temporal bones were used to measure MEPO directly. To calculate MEPO and MSG, we measured the pressure close to the eardrum and stapes velocity for sound drive and light drive using the Earlens.

          Results

          The baseline sound-driven measurements are consistent with previous reports. The average MEPO (N=4) varies from 116 to 128 dB SPL in the 0.7 to 10 kHz range, with the peak occurring at 7.6 kHz. From 0.1–0.7 kHz, it varies from 83 to 121 dB SPL. For the average MSG, a broad minimum of about 10 dB occurs in the 1–4 kHz range, above which it rises as high as 42 dB at 7.6 kHz. From 0.2 to 1 kHz, the MSG decreases linearly from about 40 dB to 10 dB.

          Conclusion

          With high output and high gain margins, the Earlens may offer broader spectrum amplification for treatment of mild to severe hearing impairment.

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          Most cited references11

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          Human middle-ear sound transfer function and cochlear input impedance.

          The middle-ear pressure gain, defined as the ear canal sound pressure to cochlear vestibule pressure gain, GME, and the ear canal sound pressure to stapes footplate velocity transfer function, SVTF, simultaneously measured in 12 fresh human temporal bones for the 0.05 to 10 kHz frequency range are reported. The mean GME magnitude reached 23.5 dB at 1.2 kHz with a slope of approximately 6 dB/octave from 0.1 to 1.2 kHz and -6 dB/octave above 1.2 kHz. From 0.1 to 0.5 kHz, the mean GME phase angle was 51 degrees, rolling off at -78 degrees /octave above this frequency. The mean SVTF magnitude reached a maximum of 0.33 mm s(-1)/Pa at 1.0 kHz with nearly the same shape in magnitude and phase angle as the mean GME. The ratio of GME and SVTF provide the first direct measurements of Z(c) in human ears. The mean Z(c) was virtually flat with a value of 21.1 acoustic GOmega MKS between 0.1 and 5.0 kHz. Above 5 kHz, the mean Z(c) increased to a maximum value of 49.9 GOmega at 6.7 kHz. The mean Z(c) angle was near 0 degrees from 0.5 to 5.0 kHz, decreasing below 0.5 kHz and above 5 kHz with peaks and valleys.
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            Measurements of human middle ear forward and reverse acoustics: implications for otoacoustic emissions.

            Middle and inner ears from human cadaver temporal bones were stimulated in the forward direction by an ear-canal sound source, and in the reverse direction by an inner-ear sound source. For each stimulus type, three variables were measured: (a) Pec--ear-canal pressure with a probe-tube microphone within 3 mm of the eardrum, (b) Vst--stapes velocity with a laser interferometer, and (c) Pv--vestibule pressure with a hydrophone. From these variables, the forward middle-ear pressure gain (M1), the cochlear input impedance (Zc), the reverse middle-ear pressure gain (M2), and the reverse middle-ear impedance (M3) are directly obtained for the first time from the same preparation. These measurements can be used to fully characterize the middle ear as a two-port system. Presently, the effect of the middle ear on otoacoustic emissions (OAEs) is quantified by calculating the roundtrip middle-ear pressure gain Gme(RT) as the product of M1 and M2. In the 2-6.8 kHz region, absolute value(Gme(RT)) decreases with a slope of -22 dB/oct, while OAEs (both click evoked and distortion products) tend to be independent of frequency; this suggests a steep slope in vestibule pressure from 2 kHz to at least 4 kHz for click evoked OAEs and to at least 6.8 kHz for distortion product OAEs. Contrary to common assumptions, measurements indicate that the emission generator mechanism is frequency dependent. Measurements are also used to estimate the reflectance of basally traveling waves at the stapes, and apically generated nonlinear reflections within the vestibule.
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              Tympanic‐Membrane Vibrations in Human Cadaver Ears Studied by Time‐Averaged Holography

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                Author and article information

                Journal
                100961504
                22035
                Otol Neurotol
                Otol. Neurotol.
                Otology & neurotology : official publication of the American Otological Society, American Neurotology Society [and] European Academy of Otology and Neurotology
                1531-7129
                1537-4505
                19 November 2015
                February 2016
                01 February 2017
                : 37
                : 2
                : 160-166
                Affiliations
                [1 ]EarLens Corporation, Menlo Park, CA
                [2 ]Department of Otolaryngology, Head and Neck Surgery, Stanford University, Palo Alto, CA
                [3 ]Department of Mechanical Engineering, Stanford University, Palo Alto, CA
                Author notes
                Corresponding Author: Sunil Puria, PhD, Phone: 650-814-0505, Fax: 650-366-9002, spuria@ 123456earlenscorp.com , c/o EarLens Corporation, 4045 Campbell Avenue, Menlo Park, CA, 94025
                Article
                PMC4712733 PMC4712733 4712733 nihpa736520
                10.1097/MAO.0000000000000941
                4712733
                26756140
                00af107f-57ab-49c4-b185-e1106a634404
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