Functional Testing of Subcutaneous Piezoelectrically Actuated Hearing Aid: Comparison With BAHA and Potential for Treating Single-sided Deafness.

OBJECTIVE: To compare the performance of a subcutaneous piezoelectrically actuated hearing aid (SPAHA) with the bone-anchored hearing aid (BAHA) and assess its effectiveness as a treatment option for conductive loss and single-sided deafness (SSD). BACKGROUND: To validate the use of the SPAHA as a bone conduction implant, its performance was compared with a widely used bone conduction implant, the BAHA. Maximum dynamic range, power consumed to deliver standard speech signals and total harmonic distortion (THD) was assessed. The transcranial attenuation was also measured to assess the SPAHA's potential to treat SSD. METHOD: Functional testing of the SPAHA and BAHA was conducted using cadaver heads. Ipsilateral and contralateral promontory velocity and the power consumption by the devices were measured at 111 different frequencies in the range of 200 to 9600 Hz. Performance metrics were derived from these measurements. RESULT: The maximum dynamic range for SPAHA was within 10 dB of that of BAHA. The THD for the SPAHA was at most 3%, slightly better than the BAHA. The power consumption by the SPAHA, whereas highly variable, was not statistically different than that of the BAHA. Transcranical attenuation in case of SPAHA was 5 to 10 dB across the measured frequency range. CONCLUSION: From observed dynamic range and THD, the speech quality delivered by the SPAHA should equal or exceed that delivered by the BAHA. To attain equivalent hearing sensation at lower frequencies, the drive voltage for SPAHA would have to be significantly higher than that for BAHA. For typical speech inputs the power consumption requirements of the SPAHA should be roughly equal to those of the BAHA. Given its performance at high frequencies, the SPAHA seems well-suited to treating SSD.

Compensating for Tissue Changes in an Ultrasonic Power Link for Implanted Medical Devices.

Ultrasonic power transfer using piezoelectric devices is a promising wireless power transfer technology for biomedical implants. However, for sub-dermal implants where the separation between the transmitter and receiver is on the order of several acoustic wavelengths, the ultrasonic power transfer efficiency (PTE) is highly sensitive to the distance between the transmitter and receiver. This sensitivity can cause large swings in efficiency and presents a serious limitation on battery life and overall performance. A practical ultrasonic transcutaneous energy transfer (UTET) system design must accommodate different implant depths and unpredictable acoustic changes caused by tissue growth, hydration, ambient temperature, and movement. This paper describes a method used to compensate for acoustic separation distance by varying the transmit (Tx) frequency in a UTET system. In a benchtop UTET system we experimentally show that without compensation, power transfer efficiency can range from 9% to 25% as a 5 mm porcine tissue sample is manipulated to simulate in situ implant conditions. Using an active frequency compensation method, we show that the power transfer efficiency can be kept uniformly high, ranging from 20% to 27%. The frequency compensation strategy we propose is low-power, non-invasive, and uses only transmit-side measurements, making it suitable for active implanted medical device applications.

Mass-spring matching layers for high-frequency ultrasound transducers: a new technique using vacuum deposition.

We have developed a technique of applying multiple matching layers to high-frequency (>30 MHz) imaging transducers, by using carefully controlled vacuum deposition alone. This technique uses a thin mass-spring matching layer approach that was previously described in a low-frequency (1 to 10 MHz) transducer design with epoxied layers. This mass- spring approach is more suitable to vacuum deposition in highfrequency transducers over the conventional quarter-wavelength resonant cavity approach, because thinner layers and more versatile material selection can be used, the difficulty in precisely lapping quarter-wavelength matching layers is avoided, the layers are less attenuating, and the layers can be applied to a curved surface. Two different 3-mm-diameter 45-MHz planar lithium niobate transducers and one geometrically curved 3-mm lithium niobate transducer were designed and fabricated using this matching layer approach with copper as the mass layer and parylene as the spring layer. The first planar lithium niobate transducer used a single mass-spring matching network, and the second planar lithium niobate transducer used a single mass-spring network to approximate the first layer in a dual quarter-wavelength matching layer system in addition to a conventional quarter-wavelength layer as the second matching layer. The curved lithium niobate transducer was press focused and used a similar mass-spring plus quarter-wavelength matching layer network. These transducers were then compared with identical transducers with no matching layers and the performance improvement was quantified. The bandwidth of the lithium niobate transducer with the single mass-spring layer was measured to be 46% and the insertion loss was measured to be -21.9 dB. The bandwidth and insertion loss of the lithium niobate transducer with the mass-spring network plus quarter-wavelength matching were measured to be 59% and -18.2 dB, respectively. These values were compared with the unmatched transducer, which had a bandwidth of 28% and insertion loss of -34.1 dB. The bandwidth and insertion loss of the curved lithium niobate transducer with the mass-spring plus quarter-wavelength matching layer combination were measured to be 68% and -26 dB, respectively; this compared with the measured unmatched bandwidth and insertion loss of 35% and -37 dB. All experimentally measured values were in excellent agreement with theoretical Krimholtz-Leedom-Matthaei (KLM) model predictions.

Fabrication and performance of a single-crystal lead magnesium niobate-lead titanate cylindrical hydrophone.

The development of a piezoelectric hydrophone based on lead magnesium niobate-lead titanate [PbMg1/3Nb2/3O3-PbTiO3 (PMN-PT)] single-crystal piezoelectric as the hydrophone substrate is reported. Although PMN-PT can possess much higher piezoelectric sensitivity than traditional lead zirconate titanate (PZT) piezoelectrics, it is highly anisotropic and therefore there is a large gain in sensitivity only when the crystal structure is oriented in a specific direction. Because of this, simply replacing the PZT substrate with a PMN-PT cylinder is not an optimal solution because the crystal orientation does not uniformly align with the circumferential axis of the hydrophone. Therefore, a composite hydrophone that maintains the optimal crystal axis around the hydrophone circumference has been developed. An 11.3 mm diameter composite hydrophone cylinder was fabricated from a single <110> cut PMN-PT rectangular plate. Solid end caps were applied to the cylinder and the sensitivity was directly compared with a solid PZT-5A cylindrical hydrophone of equal dimensions in a hydrophone test tank. The charge sensitivity showed a 9.1 dB improvement over the PZT hydrophone and the voltage sensitivity showed a 3.5 dB improvement. This was in good agreement with the expected theoretical improvements of 10.1 and 4.5 dB, respectively.

Can otoplasty impact hearing? A prospective randomized controlled study examining the effects of pinna position on speech reception and intelligibility.

OBJECTIVES: Otoplasty is a commonly performed surgical procedure that restores the ideal position of the pinna. Although the pinna is a well-recognized component of the auditory apparatus, no studies have assessed the audiological effects of this procedure. We sought to quantify the impact of pinna repositioning on speech intelligibility and reception. METHODS: Eighteen adults with normal hearing and pinnae were recruited and the pinna positions were randomized in each participant. Intracanal acoustical analysis was performed to calculate the Speech Intelligibility Index (SII). Hearing In Noise Test (HINT) with two azimuth speaker arrangement was also performed. The outcome measures were compared using paired t-tests for both pinna positions. RESULTS: The SII significantly improved with the pinna in forward position (49.3 vs. 45.8, p<0.001). HINT thresholds also improved with the pinna forward (-6.43 dB vs. -5.08 dB, p=0.0003). CONCLUSIONS: Pinna position affects audiological performance, in both speech intelligibility and speech reception in noise. These are novel findings that may impact the informed consent process and decision to treat for patients undergoing otoplasty.