Hearing Aid Treatment for Patients with Mixed Hearing Loss. Part II: Speech Recognition in Comparison to Direct Acoustic Cochlear Stimulation.

BACKGROUND: The conventional therapy for severe mixed hearing loss is middle ear surgery combined with a power hearing aid. However, a substantial group of patients with severe mixed hearing loss cannot be treated adequately with today's state-of-the-art (SOTA) power hearing aids, as predicted by the accompanying part I of this publication, where we compared the available maximum power output (MPO) and gain from technical specifications to requirements for optimum benefit using a common fitting rule. Here, we intended to validate the theoretical assumptions from part I experimentally in a mixed hearing loss cohort fitted with SOTA power hearing aids. Additionally, we compared the results with an implantable hearing device that circumvents the impaired middle ear, directly stimulating the cochlea, as this might be a better option. OBJECTIVES: Speech recognition outcomes obtained from patients with severe mixed hearing loss supplied acutely with a SOTA hearing aid were studied to validate the outcome predictions as described in part I. Further, the results obtained with hearing aids were compared to those in direct acoustic cochlear implant (DACI) users. MATERIALS AND METHODS: Twenty patients (37 ears with mixed hearing loss) were provided and fitted with a SOTA power hearing aid. Before and after an acclimatization period of at least 4 weeks, word recognition scores (WRS) in quiet and in noise were studied, as well as the speech reception threshold in noise (SRT). The outcomes were compared retrospectively to a second group of 45 patients (47 ears) using the DACI device. Based on the severity of the mixed hearing loss and the available gain and MPO of the SOTA hearing aid, the hearing aid and DACI users were subdivided into groups with prediction of sufficient, partially insufficient, or very insufficient hearing aid performance. RESULTS: The patients with predicted adequate SOTA hearing aid performance indeed showed the best WRS in quiet and in noise when compared to patients with predicted inferior outcomes. Insufficient hearing aid performance at one or more frequencies led to a gradual decrease in hearing aid benefit, validating the criteria used here and in the accompanying paper. All DACI patients showed outcomes at the same level as the adequate hearing aid performance group, being significantly better than those of the groups with inadequate hearing aid performance. Whereas WRS in quiet and noise were sensitive to insufficient gain or output, showing significant differences between the SOTA hearing aid and DACI groups, the SRT in noise was less sensitive. CONCLUSIONS: Limitations of outcomes in mixed hearing loss individuals due to insufficient hearing aid performance can be accurately predicted by applying a commonly used fitting rule and the 35-dB dynamic range rule on the hearing aid specifications. Evidently, when outcomes in patients with mixed hearing loss using the most powerful hearing aids are insufficient, bypassing the middle ear with a powerful active middle ear implant or direct acoustic implant can be a promising alternative treatment.

Prevalence of potential candidates for electric-acoustic stimulation implant in a hearing-impaired population.

OBJECTIVE: To estimate the prevalence of potential electric-acoustic stimulation (EAS) implant candidates in a hearing-impaired population through a review of auditory examinations. METHODS: In total, 7356 patients underwent audiometric examination in our department between 2011 and 2014. The prevalence of patients meeting the audiometric criteria for EAS and standard cochlear implant (CI) was assessed. RESULTS: The percentage of EAS implant candidates meeting the pure-tone audiometric criteria was 0.71% (n=34) among the hearing-impaired individuals (n=4758) examined in our department, whereas 2.52% (n=120) met the criteria for standard CI. Among the 34 EAS implant candidates, 2 individuals (5.83%) received EAS implant surgery after approval of the EAS device in Japan. CONCLUSIONS: There was a lower prevalence of EAS implant candidates than standard CI candidates. Nevertheless, healthcare professionals should carefully examine the audiograms of patients with high frequency hearing loss with regard to meeting the indication criteria for EAS implant. This will enable patients to gain access to adequate information relating to further examinations and treatment options.

Does hearing in response to soft-tissue stimulation involve skull vibrations? A within-subject comparison between skull vibration magnitudes and hearing thresholds.

Hearing can be elicited in response to bone as well as soft-tissue stimulation. However, the underlying mechanism of soft-tissue stimulation is under debate. It has been hypothesized that if skull vibrations were the underlying mechanism of hearing in response to soft-tissue stimulation, then skull vibrations would be associated with hearing thresholds. However, if skull vibrations were not associated with hearing thresholds, an alternative mechanism is involved. In the present study, both skull vibrations and hearing thresholds were assessed in the same participants in response to bone (mastoid) and soft-tissue (neck) stimulation. The experimental group included five hearing-impaired adults in whom a bone-anchored hearing aid was implanted due to conductive or mixed hearing loss. Because the implant is exposed above the skin and has become an integral part of the temporal bone, vibration of the implant represented skull vibrations. To ensure that middle-ear pathologies of the experimental group did not affect overall results, hearing thresholds were also obtained in 10 participants with normal hearing in response to stimulation at the same sites. We found that the magnitude of the bone vibrations initiated by the stimulation at the two sites (neck and mastoid) detected by the laser Doppler vibrometer on the bone-anchored implant were linearly related to stimulus intensity. It was therefore possible to extrapolate the vibration magnitudes at low-intensity stimulation, where poor signal-to-noise ratio limited actual recordings. It was found that the vibration magnitude differences (between soft-tissue and bone stimulation) were not different than the hearing threshold differences at the tested frequencies. Results of the present study suggest that bone vibration magnitude differences can adequately explain hearing threshold differences and are likely to be responsible for the hearing sensation. Thus, the present results support the idea that bone and soft-tissue conduction could share the same underlying mechanism, namely the induction of bone vibrations. Studies with the present methodology should be continued in future work in order to obtain further insight into the underlying mechanism of activation of the hearing system.

A comparative study of MED-EL FMT attachment to the long process of the incus in intact middle ears and its attachment to disarticulated stapes head.

The Vibrant Soundbridge© (VSB) active middle-ear implant provides an effective treatment for mild-to-severe sensorineural hearing loss in the case of normal middle ear anatomy and mixed hearing loss in middle ear malformation. The VSB floating mass transducer (FMT), with proper couplers, can be installed on various structures of the ossicular chain, e.g., the short and long process of the incus, the stapes head, and the stapes footplate. A long process (LP) coupler is most commonly used for FMT attachment to the long process of the incus with intact ossicular chain, while CliP and Bell couplers are two standardized and reliable methods for FMT attachment to the stapes head with missing incus and malleus. However, the difference and relationship of the vibration properties among these three FMT couplers remain unclear. In the present study, the stapes footplate velocity responses of the LP, CliP, and Bell couplers have been investigated in eight fresh temporal bones (TBs) to evaluate the vibration properties of these three couplers. Normal and reconstructed middle ear transfer functions (METFs) were determined from laser Doppler vibrometer (LDV) measurements. A mastoidectomy and a posterior tympanotomy were performed to expose the ossicular chain. The METFs of the normal middle ear and middle ear with LP-FMT-coupler were compared under acoustic stimulation, thus the mass effect of the FMT with LP coupler was evaluated. Additional comparisons were made between the stapes footplate vibrations of the LP-FMT-coupler (with the intact ossicular chain at the long process of the incus), CliP-FMT-coupler and Bell-FMT-coupler on the stapes head (after incus and malleus removed) under active electromechanical stimulation. After the installation of CliP-FMT-coupler and Bell-FMT-coupler to the middle ear, the average velocity amplitude of the stapes footplate, comparing to the LP-FMT-coupler, was about 15 dB higher between 1 and 6 kHz, and 10 dB lower at about 0.5 kHz. Quantitatively, there was no significant difference between the CliP-FMT-coupler and Bell-FMT-coupler. According to our study, installation of CliP-FMT-coupler or Bell-FMT-coupler on the stapes head provides considerable improvement of the middle ear mechanical and functional responses, comparing with the LP-FMT-coupler in the temporal bone experiments. Moreover, the installation of the Bell-FMT-coupler to the stapes head produces essentially the same footplate velocity responses in comparison to the CliP-FMT-coupler.

Identification of induced and naturally occurring conductive hearing loss in mice using bone conduction.

While many mouse models of hearing loss have been described, a significant fraction of the genetic defects in these models affect both the inner ear and middle ears. A common method used to separate inner-ear (sensory-neural) from middle-ear (conductive) pathologies in the hearing clinic is the combination of air-conduction and bone-conduction audiometry. In this report, we investigate the use of air- and bone-conducted evoked auditory brainstem responses to perform a similar separation in mice. We describe a technique by which we stimulate the mouse ear both acoustically and via whole-head vibration. We investigate the sensitivity of this technique to conductive hearing loss by introducing middle-ear lesions in normal hearing mice. We also use the technique to investigate the presence of an age-related conductive hearing loss in a common mouse model of presbycusis, the BALB/c mouse.

The bone conduction implant: Clinical results of the first six patients.

OBJECTIVE: To investigate audiological and quality of life outcomes for a new active transcutaneous device, called the bone conduction implant (BCI), where the transducer is implanted under intact skin. DESIGN: A clinical study with sound field audiometry and questionnaires at six-month follow-up was conducted with a bone-anchored hearing aid on a softband as reference device. STUDY SAMPLE: Six patients (age 18-67 years) with mild-to-moderate conductive or mixed hearing loss. RESULTS: The surgical procedure was found uneventful with no adverse events. The first hypothesis that BCI had a statistically significant improvement over the unaided condition was proven by a pure-tone-average improvement of 31.0 dB, a speech recognition threshold improvement in quiet (27.0 dB), and a speech recognition score improvement in noise (51.2 %). At speech levels, the signal-to-noise ratio threshold for BCI was - 5.5 dB. All BCI results were better than, or similar to the reference device results, and the APHAB and GBI questionnaires scores showed statistically significant improvements versus the unaided situation, supporting the second and third hypotheses. CONCLUSIONS: The BCI provides significant hearing rehabilitation for patients with mild-to-moderate conductive or mixed hearing impairments, and can be easily and safely implanted under intact skin.

Wireless and acoustic hearing with bone-anchored hearing devices.

OBJECTIVE: The efficacy of wireless connectivity in bone-anchored hearing was studied by comparing the wireless and acoustic performance of the Ponto Plus sound processor from Oticon Medical relative to the acoustic performance of its predecessor, the Ponto Pro. STUDY SAMPLE: Nineteen subjects with more than two years' experience with a bone-anchored hearing device were included. Thirteen subjects were fitted unilaterally and six bilaterally. DESIGN: Subjects served as their own control. First, subjects were tested with the Ponto Pro processor. After a four-week acclimatization period performance the Ponto Plus processor was measured. In the laboratory wireless and acoustic input levels were made equal. In daily life equal settings of wireless and acoustic input were used when watching TV, however when using the telephone the acoustic input was reduced by 9 dB relative to the wireless input. RESULTS: Speech scores for microphone with Ponto Pro and for both input modes of the Ponto Plus processor were essentially equal when equal input levels of wireless and microphone inputs were used. Only the TV-condition showed a statistically significant (p <5%) lower speech reception threshold for wireless relative to microphone input. In real life, evaluation of speech quality, speech intelligibility in quiet and noise, and annoyance by ambient noise, when using landline phone, mobile telephone, and watching TV showed a clear preference (p <1%) for the Ponto Plus system with streamer over the microphone input. Due to the small number of respondents with landline phone (N = 7) the result for noise annoyance was only significant at the 5% level. CONCLUSION: Equal input levels for acoustic and wireless inputs results in equal speech scores, showing a (near) equivalence for acoustic and wireless sound transmission with Ponto Pro and Ponto Plus. The default 9-dB difference between microphone and wireless input when using the telephone results in a substantial wireless benefit when using the telephone. The preference of wirelessly transmitted audio when watching TV can be attributed to the relatively poor sound quality of backward facing loudspeakers in flat screen TVs. The ratio of wireless and acoustic input can be easily set to the user's preference with the streamer's volume control.

Vibromechanical assessment of active middle ear implant stimulation in simulated middle ear effusion: a temporal bone study.

HYPOTHESIS: Active middle ear implant (AMEI) generated vibromechanical stimulation of the ossicular chain (ossicular chain vibroplasty [OCV]) or the round window (round window vibroplasty [RWV]) is not significantly affected by simulated middle ear effusion in a human temporal bone model. BACKGROUND: OCV and RWV may be employed for sensorineural, mixed, and conductive hearing losses. Although middle ear effusions may be encountered across patient populations, little is known about how effusions may affect AMEI vibromechanical efficiency. METHODS: Laser Doppler vibrometry of stapes velocities (SVs) were performed in a human temporal bone model of simulated effusion (N = 5). Baseline measurements to acoustic sinusoidal stimuli, OCV, and RWV (0.25-8 kHz) were made without effusion. The measurements were repeated with simulated middle ear effusion and compared with baseline measurements. Data were analyzed across 3 frequency bands: low (0.25-1 kHz), medium (1-3 kHz), and high (3-8 kHz). RESULTS: Acoustic stimulation with simulated middle ear effusion resulted in a significant (p < 0.001) frequency-dependent attenuation of SVs of 4, 10, and 7 dB (low, medium, and high ranges, respectively). OCV in simulated effusion resulted in attenuated SVs of 1, 5, and 14 dB (low, medium, and high) compared to without effusion; however, this attenuation was not significant (p = 0.07). Interestingly, in the setting of RWV, simulated effusion resulted in significantly (p = 0.001) increased SVs of 16, 11, and 8 dB (low, medium, and high). A 3-dB variance in AMEI efficiency was observed in repeated measurements in a single temporal bone. CONCLUSION: The efficiency of OCV was not significantly affected by the presence of a middle ear effusion. Improved efficiency, however, was observed with RWV.

[Effect of fenestration of the cochlea on the vibration of the round window membrane]. / Effekt der Promontorialfensterung auf die Schwingung der Rundfenstermembran - experimentelle Studie.

Drilling a promontory window and coupling an FMT into the scala tympani may be a surgical alternative to stapes surgery in obliterative tympanosclerosis. Aim of this experimental study on human temporal bones was to measure changes of the acoustic transfer function from the tympanic membrane to the round window membrane after drilling a promontory window and insertion of a floating mass transducer.Laser vibrometry and acoustic measurements were performed on 11 temporal bone preparations equipped with a microphone attached to the round window. Calibrations were carried out to allow determination of SPLs affecting the cochlea after drilling a promontory window leaving the membranous inner ear intact and after insertion of an FMT into the cavity (with or without slight pressure).Drilling a promontory window does influence the transfer function. Insertion of the FMT with additional slight pressure further changes the transfer function.The presence of a promontory window changes the acoustic transfer function to the round window. Further investigations are needed to correlate the qualitative results with the audiological results after "third window vibroplasty" (inserted floating mass transducer without stimulation).

[On the reliability of brainstem electric response audiometry (BERA)]. / Zur Verlässlichkeit hirnstammaudiometrischer Hörschwellenbestimmungen.

BACKGROUND: Brainstem electric response audiometries (BERA) are in clinical use for a number of years. The aim of our study was to evaluate data regarding the long-term reliability of BERA-determined frequency specific thresholds in hearing disabled children. MATERIAL AND METHODS: In a group of 97 hearing disabled children we sought to compare Notched-Noise- (NN) BERA threshold as well as Click-BERA thresholds taken shortly after birth with behavioral audiometry thresholds determined after 3.2 years (mean). RESULTS: We found a significant correlation between both BERA methods and the behavioral tests. However, the correlation coefficients for NN-BERA were higher than for Click-BERA thresholds. CONCLUSION: Our results provide evidence for a high reliability of the NN-BERA for characterization of early onset hearing disabilities in children. Our data suggest that pathologic findings in the Click-BERA should always be followed by a frequency specific analysis with NN-BERA.

Oval window membrane vibroplasty for direct acoustic cochlear stimulation: treating severe mixed hearing loss in challenging middle ears.

OBJECTIVE: To date, all the Vibrant Soundbridge (VSB) applications have managed to stimulate the inner ear indirectly. Our objective was to present a new VSB application for direct inner ear stimulation. STUDY DESIGN: Prospective cohort study. SETTINGS: Tertiary, referral center PATIENTS: Three patients with previous middle ear surgery and moderate-to-severe ipsilateral, mixed hearing loss. INTERVENTIONS: Oval window membrane vibroplasty (OWMV) for direct acoustic cochlear stimulation. A total ossicular replacement prosthesis (TORP) was attached to the floating mass transducer (FMT). Then, the stapes footplate was perforated, and the tip of the FMT-TORP assembly was advanced approximately 1 mm into the inner ear. A silicon ring was placed around the TORP's tip to prevent it from slipping deeper into the inner ear. MAIN OUTCOME MEASURE: Audiologic assessment involving pure-tone audiometry, aided and unaided free-field audiometry, Freiburg monosyllabic word test, and registration of any complications. RESULTS: OWMV resulted in an average functional hearing gain of 36.1 dB (range, 24.2-47.5 dB). Although the greatest amplification was observed in the higher frequencies, there also was a significant improvement in the lower frequencies. The surgery was not related to any difficulties; vertigo, inner ear trauma, or further complications did not occur. CONCLUSION: We present a new method for direct acoustic cochlear stimulation using an active middle ear implant. The preliminary results show that OWMV is a promising and safe option for treating moderate and severe hearing loss, even in challenging cases with previous middle ear operations or fixed stapes footplate.

Sound-induced vertigo due to bone dehiscence of the lateral semicircular canal.

Dehiscence of the lateral semicircular canal (LSCD) has been reported much but mainly in association with cholesteatoma and canal wall down mastoidectomy, while idiopathic LSCD was rarely reported. Bassim reported one case with lateral semicircular canal dehiscence, but presented no vestibular or auditory symptoms. The patient in this study complained significant sound-induced vertigo and autophony in his right ear. The axis of nystagmus was orthogonal to the lateral semicircular canal, and no torsional or vertical motions were observed, so pathology of the lateral semicircular canal was preferentially considered. Benign paroxysmal positional vertigo was excluded since vertigo attacks had no relation to the change of head position. The dehiscence of the right lateral semicircular canal was then confirmed through the high-resolution temporal bone computer tomography scan and the reconstructed images. The cause of the LSCD is poorly understood, since no history of head trauma, otological infection or surgery was documented.

Performance considerations of prosthetic actuators for round-window stimulation.

Round-window (RW) stimulation has improved speech perception in patients with mixed hearing loss. In cadaveric temporal bones, we recently showed that RW stimulation with an active prosthesis produced differential pressure across the cochlear partition (a measure related to cochlear transduction) similar to normal forward sound stimulation above 1 kHz, when contact area between the prosthesis and RW is secured. However, there is large variability in the hearing improvement in patients implanted with existing modified prosthesis. This is likely because the middle-ear prosthesis used for RW stimulation was designed for a very different application. In this paper, we utilize recently developed experimental techniques that allow for the calculation of performance specifications for a RW actuator. In cadaveric human temporal bones (N=3), we simultaneously measure scala vestibuli and scala tympani intracochlear pressures, as well as stapes velocity and ear-canal pressure, during normal forward sound stimulation as well as reverse RW stimulation. We then calculate specifications such as the impedance the actuator will need to oppose at the RW, the force with which it must push against the RW, and the velocity and distance by which it must move the RW to obtain cochlear stimulation equivalent to that of specific levels of ear-canal pressure under normal sound stimulation. This information is essential for adapting existing prostheses and for designing new actuators specifically for RW stimulation.

Electrocochleographic and mechanical assessment of round window stimulation with an active middle ear prosthesis.

Mechanical stimulation of the round window (RW) with an active middle ear prosthesis (AMEP) has shown functional benefit in clinical reports in patients with mixed hearing loss (MHL). Further objective physiological data on the efficacy of RW stimulation is needed, however, to demonstrate that RW stimulation with an AMEP can generate input to the inner ear comparable to acoustic input. Cochlear microphonic (CM) and mechanical (stapes velocity) responses to sinusoidal stimuli were measured by electrode and laser Doppler vibrometry in eight chinchillas in response to normal acoustic stimulation via sealed calibrated insert earphones and to AMEP stimulation (Otologics MET, Boulder, CO, USA) of the RW with and without lateral ossicular chain disarticulation. CM thresholds for acoustic stimulation were frequency dependent and ranged from 16 to 50 dB SPL. CM thresholds measured with RW stimulation ranged from -14 to 35 dBmV with an intact middle ear chain and from -7 to 36 dBmV after lateral ossicular chain disarticulation. Acoustically, stapes velocity maxima was observed at approximately 700 Hz and minima at approximately 2.65 kHz. With application of the AMEP to the RW, peak stapes velocity was observed at 2-3 kHz. The equivalent ear canal sound pressure level (L(E)(max)dB SPL) evoked by RW stimulation with the AMEP was 60-105 dB SPL for the intact middle ear and 70-100 dB SPL after ossicular chain disarticulation. Stimulating the inner ear through the RW with an AMEP produces evoked responses (CM) comparable to normal acoustic input. When adjusted for threshold (due to unit differences, dB SPL or dB mV), the sensitivity of the CM (slope) for acoustic was comparable to sensitivities obtained by AMEP stimulation of the RW. Mechanical stimulation of the RW with an AMEP produces cochlear responses (CMs) and stapes velocities that are functionally equivalent to acoustic stimulation.

Infant air and bone conduction tone burst auditory brain stem responses for classification of hearing loss and the relationship to behavioral thresholds.

OBJECTIVE: A clinical protocol for diagnosing hearing loss (HL) in infants designed to meet early intervention guidelines was used with the goals of providing normative data for (1) frequency-specific tone burst auditory brain stem response (TBABR) thresholds by air conduction (AC) and bone conduction (BC) in early infancy used to classify type and severity of HL, (2) ear-specific behavioral thresholds for these same infants by 1 yr of age, and (3) the relationship between TBABR thresholds and behavioral thresholds for this group of infants. DESIGN: AC- and BC-TBABRs were measured in young infants (mean age, <3 mo) under natural sleep to classify the type and severity of HL (conductive, sensorineural, or mixed). A small group of normal-hearing adults undergoing the same TBABR protocol served as a control group. Threshold and latency data for AC- and BC-ABR were analyzed for infants classified as having normal hearing and for those with and without conductive HL. The ability to detect conductive HL based on ABR latencies evoked by clicks presented at 80 dB nHL was assessed. Behavioral thresholds using visual reinforcement audiometry (VRA) were measured in infants at a mean age of approximately 10 mo. The relationship between TBABR and behavioral thresholds obtained in infancy was analyzed, and the prediction of behavioral thresholds from TBABR thresholds was examined. RESULTS: Mean TBABR thresholds in young infants with normal hearing tested under natural sleep were similar to previously published data. The relationship between AC- and BC-TBABR thresholds differed as a function of stimulus frequency for infants but not adults. A mean air-bone gap (ABG) of 15 dB was present at 500 Hz even in normal-hearing infants, with those infants classified as having conductive HL presenting with substantially larger ABGs. Wave V latency functions for AC- and BC-TBABR also differed between infants and adults as a function of frequency. Infant BC-TBABR latencies were well matched between those with normal hearing and conductive HL, whereas AC-TBABR latency functions separated these groups. Mean VRA thresholds using insert phones in normal-hearing infants tested were between 14 and 17 dB HL for all three test frequencies at a mean age of 9.7 mo. Correlations between TBABR and VRA thresholds, both obtained during infancy, were strong for all three test frequencies (r = 0.86, 0.90, and 0.91 for 500, 2000, and 4000 Hz, respectively). CONCLUSIONS: AC- and BC-TBABR results can be readily obtained in young infants under natural sleep and were used to classify the type of HL based on the absolute threshold and the size of the ABG. Differences in wave V latency functions for TBABR by AC and BC and wave I and V latencies of the high-level click ABR also distinguish between infants with and without TBABR ABGs. Ear-specific behavioral responses can be obtained at levels under 20 dB HL in normal-hearing infants younger than 1 yr using VRA, and these behavioral thresholds correlate well with TBABR thresholds obtained on average 6.5 mo previously in this population. The current results suggest that protocols for obtaining AC- and BC-TBABR and behavioral thresholds that meet guidelines for early intervention are clinically feasible.

The effects of cueing temporal and spatial attention on word recognition in a complex listening task in hearing-impaired listeners.

In a complex listening situation such as a multiperson conversation, the demands on an individual's attention are considerable: There will often be many sounds occurring simultaneously, with continual changes in source and direction. A laboratory analog of this was designed to measure the benefit that helping attention (by visual cueing) would have on word identification. These words were presented unpredictably but were sometimes cued with a temporal cue or a temporal-and-spatial cue. Two groups of hearing-impaired, older-adult listeners participated, 57 unaided and 19 aided. There was a small effect of cueing: The cues gave a 2% benefit in word identification. A variety of subsidiary measures were collected, including the Test of Everyday Attention and the Speech, Spatial, & Qualities of Hearing Questionnaire, but their links with the benefits of cueing were few. The results demonstrate the difficulty of cueing attention to improve word recognition in a complex listening situation.