Rodney C. Perkins

System and method for delivering customized audio data

A method for providing customized audio data products that includes the steps of (1) storing a machine readable hearing profile for a customer, (2) accepting via a data input device or data network for example, machine readable orders from the customer for a particular audio data product, (3) associating the hearing profile for the customer with the particular audio data product, (4) modifying the particular audio data product according to the hearing profile to produce a customized audio data product, (5) delivering the customized audio data product to the customer, for example via a network or by a machine readable storage medium, (6) accepting feedback from the customer concerning the subjective performance of the customized audio data product, and (7) modifying the hearing profile in response to the feedback is provided. A system that includes a source of an audio data product, such as an Internet accessible registry, and processing resources that are configured to receive a request for the audio data product, and to associate the audio data product with a customer hearing profile is provided.

Flextensional microphones for implantable hearing devices

This relates to flextensional microphones which are made up of a piezoelectric substrate having opposing surfaces, typically parallel surfaces when the substrate is crystalline or ceramic, and at least one sound receiving surface physically tied to the piezoelectric substrate. The microphones are at least partially isolated via a biocompatible material, e.g., by a covering or a coating. The inventive microphones may be subcutaneously implanted. The microphones may be used as components of surgically implanted hearing aid systems or as components of hearing devices known as cochlear implants. Preferably the microphones are used in arrays and when used as a component of a hearing assistance or replacement device, are used in conjunction with a source of feedback information, usually another microphone. The feedback information usually relates to sound re-emitted from physical portions of the ear, e.g., the eardrum, where those portions have been directly or indirectly driven by the actuator of the implanted hearing aid.

Malleus-to-footplate ossicular reconstruction prosthesis positioning: cochleovestibular pressure optimization.

Aims: To determine 1) the best position for hydroxylapatite malleus-to-footplate (MFP), ossicular replacement prosthesis (ORP) in reconstructed ears, and 2) whether preserving the stapes superstructure (SS), when present, has acoustic advantages. Background: Positioning of the MFP-ORP head beneath the neck of the malleus may produce maximal force, whereas positioning beneath the manubrium of the malleus may produce the greatest displacement. It is not clear which is the optimal placement position. In addition, we look at the effect of the SS on sound transmission to the inner ear in ossicular reconstruction. Methods: The ear-canal air pressure and vestibular hydro-pressure were measured in human cadaver temporal bones with incus intact, removed, and replaced with the MFP-ORP; the ORP head was placed at three different positions on the malleus (head, mid-manubrium, and umbo) while keeping its base at the center of stapes footplate with intact or removed stapes SS. The vestibular pressure ratio between the ear with intact incus and MFP-ORP reconstructed ear is defined as Lmfp, the loss caused by the prosthesis in relation to the normal ossicular chain. Results: The mean magnitude of Lmfp, averaged in the important speech frequency region of 0.5 to 3 kHz, is approximately 7.8 dB at the neck with stapes SS. In comparison, mean magnitude of Lmfp for mid-manubrium without stapes SS is 15 dB (p = 0.04), and with the stapes SS it is 16 dB (p = 0.05), whereas at the umbo without SS it is 15 dB (p = 0.03). In the 8 kHz region, the mean magnitude of Lmfp is approximately 1 dB with the stapes SS intact and approximately 8.5 dB when it was removed (p < 0.09). Conclusion: There are significant physiologic advantages to placing the hydroxylapatite MFP-ORP beneath the neck of the malleus and preserving the SS.

The EarLens System: New Sound Transduction Methods

The hypothesis is tested that an open-canal hearing device, with a microphone in the ear canal, can be designed to provide amplification over a wide bandwidth and without acoustic feedback. In the design under consideration, a transducer consisting of a thin silicone platform with an embedded magnet is placed directly on the tympanic membrane. Sound picked up by a microphone in the ear canal, including sound-localization cues thought to be useful for speech perception in noisy environments, is processed and amplified, and then used to drive a coil near the tympanic-membrane transducer. The perception of sound results from the vibration of the transducer in response the electromagnetic field produced by the coil. Sixteen subjects (ranging from normal-hearing to moderately hearing-impaired) wore this transducer for up to a 10-month period, and were monitored for any adverse reactions. Three key functional characteristics were measured: (1) the maximum equivalent pressure output (MEPO) of the transducer; (2) the feedback gain margin (GM), which describes the maximum allowable gain before feedback occurs; and (3) the tympanic-membrane damping effect (D(TM)), which describes the change in hearing level due to placement of the transducer on the eardrum. Results indicate that the tympanic-membrane transducer remains in place and is well tolerated. The system can produce sufficient output to reach threshold for those with as much as 60 dBHL of hearing impairment for up to 8 kHz in 86% of the study population, and up to 11.2 kHz in 50% of the population. The feedback gain margin is on average 30 dB except at the ear-canal resonance frequencies of 3 and 9 kHz, where the average was reduced to 12 dB and 23 dB, respectively. The average value of D(TM) is close to 0 dB everywhere except in the 2-4 kHz range, where it peaks at 8dB. A new alternative system that uses photonic energy to transmit both the signal and power to a photodiode and micro-actuator on an EarLens platform is also described.

Preliminary evaluation of a light-based contact hearing device for the hearing impaired.

Objective To assess the safety, stability, and performance of the broad-spectrum, light-based contact hearing device (CHD) on listeners with hearing impairment. Study Design Feasibility study. Setting Single-site research and development facility. Participants Thirteen participants with symmetric mild-to-severe sensorineural hearing impairment had the CHD placed bilaterally. Intervention A custom-molded light-activated tympanic contact actuator (TCA) was placed into each ear by a physician, where it stayed in contact with the umbo and a portion of the medial wall of the ear canal for 4 months. Each CHD was calibrated and programmed to provide appropriate broad-spectrum amplification. Main Outcome Measures Safety was determined through routine otologic examinations. Aided and pre-TCA-insertion unaided audiometric thresholds (functional gain), maximum gain before feedback, tympanic membrane damping, Reception Threshold for Sentences (RTS), and Abbreviated Profile of Hearing Aid Benefit (APHAB) measurements were made to characterize system performance as well as the benefits of amplification via the CHD. Results The TCAs remained on participants’ ears for an average total of 122 days, without causing signs of inflammation or infection, and there were no serious device-related adverse events. Measured average maximum output of 90 to 110 dB SPL in the range of 0.25 to 10 kHz, average maximum gain before feedback of 40 dB, and functional gain through 10 kHz show extended-bandwidth broad-spectrum output and gain. RTS results showed significant aided improvements of up to 2.8 dB, and APHAB results showed clinically significant aided benefits in 92% of participants (11/12). Conclusion The safety, stability, and performance demonstrated in this initial 4-month study suggest that the CHD may offer a feasible way of providing broad-spectrum amplification appropriate to treat listeners with mild-to-severe hearing impairment.

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

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 nonsurgical Earlens consists of a light-activated balanced-armature transducer placed on the tympanic membrane (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, with a significantly higher MSG. MEPO provides an important fitting guideline. Methods: Four fresh human cadaveric temporal bones were used to measure MEPO directly. To calculate MEPO and MSG, we measured the pressure close to the eardrum and the 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 to 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 to 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 approximately 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.

The EarLens Photonic Transducer: Extended Bandwidth

Objective: Light pulses transmitted through the external auditory canal are captured by a photodetector on a tympanic membrane contact transducer creating a current, which activates a micro-motor. The hypothesis that an extended bandwidth (10 kHz) contact transducer residing on the tympanic membrane will improve speech understanding in noise is tested. Method: Reception thresholds of sentences (RTS) were measured with target speech at -45° and two talkers at +45°, simulating a photonic transducer on (1) normal and (2) hearing-impaired subjects. HINT sentences and masking speech materials were recorded at 24-kHz bandwidth and low-pass filtered at 4, 6, 8, and 10 kHz. Results: For normal hearing subjects (n = 12), the mean RTS was -17.4, -19.1, -19.3, and -20.7 dB for 4, 6, 8, and 10 kHz respectively. For hearing impaired subjects (n = 12), the RTS unaided full bandwidth was -10.0 dB and -10.0, -11.9, -12.2, and -12.4 dB for aided 4, 6, 8, and 10 kHz respectively. The results indicate significant improvements of 3.3 dB (P < .001) in normal hearing and 2.4 dB (P = .02) for hearing impaired subjects for the 10 kHz vs the 4 kHz bandwidths. Initial measurements with the IDE-approved photonic hearing device are consistent with the simulation study. Conclusion: The results suggest that acoustic cues above 4 kHz in a hearing device can greatly enhance the ability to hear target speech in noisy environments. This opens up possibilities for a unique hearing system using only light to transmit sound to vibrate the tympano-ossicular system.

Light-Driven Contact Hearing Aid for Broad-Spectrum Amplification: Safety and Effectiveness Pivotal Study.

Objective: Demonstrate safety and effectiveness of the light-driven contact hearing aid to support FDA clearance. Study Design: A single-arm, open-label investigational-device clinical trial. Setting: Two private-practice and one hospital-based ENT clinics. Patients: Forty-three subjects (86 ears) with mild-to-severe bilateral sensorineural hearing impairment. Intervention: Bilateral amplification delivered via a light-driven contact hearing aid comprising a Tympanic Lens (Lens) with a customized platform to directly drive the umbo and a behind-the-ear sound processor (Processor) that encodes sound into light pulses to wirelessly deliver signal and power to the Lens. Main Outcome Measures: The primary safety endpoint was a determination of “no change” (PTA4 < 10 dB) in residual unaided hearing at the 120-day measurement interval. The primary efficacy endpoint was improvement in word recognition using NU-6 at the 30-day measurement interval over the baseline unaided case. Secondary efficacy endpoints included functional gain from 2 to 10 kHz and speech-in-noise improvement over the baseline unaided case using both omnidirectional and directional microphones. Results: The results for the 86 ears in the study determined a mean change of −0.40 dB in PTA4, indicating no change in residual hearing (p < 0.0001). There were no serious device- or procedure-related adverse events, or unanticipated adverse events. Word recognition aided with the Earlens improved significantly (p < 0.0001) over the unaided performance, by 35% rationalized arcsine units on average. Mean functional gain was 31 dB across 2 to 10 kHz. The average speech-recognition threshold improvement over the unaided case for the Hearing in Noise Test was 0.75 dB (p = 0.028) and 3.14 dB (p < 0.0001) for the omnidirectional and directional microphone modes, respectively. Conclusion: The safety and effectiveness data supported a de novo 510(k) submission that received clearance from the FDA.

Maximum equivalent pressure output and maximum stable gain of a light-activated contact hearing device that mechanically stimulates the umbo: Temporal bone measurements

The non-surgical contact hearing device (CHD) consists of a light-activated balanced-armature tympanic-membrane transducer (TMT) that drives the middle ear through contact with the umbo, and a behind-the-ear unit with a widely vented light-emitter Assembly inserted into the ear canal that encodes amplified sound into pulses of light that drive and power the TMT. In comparison to acoustic hearing aids, the CHD is designed to provide higher levels of maximum equivalent pressure output (MEPO) over a broader frequency range and a significantly higher maximum stable gain (MSG). No artificial middle-ear model yet exists for testing the CHD, so we instead measured it using fresh human cadaveric temporal bones. To calculate the MEPO and MSG, we measured the pressure close to the eardrum and stapes velocity for sound drive and light drive using the CHD. The baseline sound-driven measurements are consistent with previous reports in temporal bones. The average MEPO (N = 4) varies from 116 to 128 dB SPL in the 0.7 to...