Direct Acoustic Cochlear Implant Research Articles

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.

Alteration of the relative vibration of the round window membrane after implantation of a direct acoustic cochlear implant

Objective: Subjects implanted with a Direct Acoustic Cochlear Implant (DACI) show improvements in their bone conduction (BC) thresholds after surgery. We hypothesised that a new pathway for BC sound is created via the DACI. The aim of this study was to investigate the contribution of this pathway to the cochlear response via measurements of the promontory and round window membrane (RWM) velocities while stimulating with a conventional bone conductor.Design: This study was a cadaver head study with a repeated measures study design.Study Sample: Eight ears of five fresh-frozen cadaveric whole heads were investigated in this trial.Results: After DACI implantation the promontory and RWM velocities did not change significantly in the frequency range 0.5–2 kHz when the DACI was switched off.Conclusions: No significant changes in the relative vibration magnitude of the RWM after DACI implantation were observed. The improvements in BC thresholds seen in patients implanted with a DACI very likely have their origin in the changed impedance at the oval window after DACI surgery leading to a more efficient contribution from the inner ear components to BC sound.

Development and validation of a method to record electrophysiological responses in direct acoustic cochlear implant subjects

Acoustic hearing implants, such as direct acoustic cochlear implants (DACIs), can be used to treat profound mixed hearing loss. Electrophysiological responses in DACI subjects are of interest to confirm auditory processing intra-operatively, and to assist DACI fitting postoperatively. We present two related studies, focusing on DACI artifacts and electrophysiological measurements in DACI subjects, respectively. In the first study we aimed to characterize DACI artifacts, to study the feasibility of measuring frequency-specific electrophysiological responses in DACI subjects. Measurements of DACI artifacts were collected in a cadaveric head to disentangle possible DACI artifact sources and compared to a constructed DACI artifact template. It is shown that for moderate stimulation levels, DACI artifacts are mainly dominated by the artifact from the radio frequency (RF) communication signal, that can be modeled if the RF encoding protocol is known. In a second study, the feasibility of measuring intra-operative responses, without applying the RF artifact models, in DACI subjects is investigated. Auditory steady-state and brainstem responses were measured intra-operatively in three DACI subjects, immediately after implantation, to confirm proper DACI functioning and coupling to the inner ear. Intra-operative responses could be measured in two of the three tested subjects. Absence of intra-operative responses in the third subject can possibly be explained by the hearing loss, attenuation of intra-operative responses, the difference between electrophysiological and behavioral threshold, and a temporary threshold shift due to the DACI surgery. In conclusion, RF artifacts can be modeled, such that electrophysiological responses to frequency-specific stimuli could possibly be measured in DACI subjects, and intra-operative responses in DACI subjects can be obtained.

A Role for Acoustic Stimulation in Advanced Otosclerosis: Direct Acoustic Cochlear Implant versus Cochlear Implant

Recent findings support the efficacy of the direct acoustic cochlear implant (DACI) in patients with advanced otosclerosis whose rehabilitation is very challenging. Standard treatment consists of stapes surgery combined with hearing aids or a cochlear implant (CI). CI surgery, however, is often challenging depending on the grade of otosclerosis. This study aims to compare speech perception scores in quiet and noise of 6 DACI and 12 CI patients with advanced otosclerosis at 3 and 12 months after fitting. Preoperative computed tomographic scans of all patients were scored by experts using an existing otosclerosis grading system (stages 1–3). Speech perception in quiet was significantly better for DACI compared to CI users at 3 months after fitting. At 12 months, no difference was found between DACI and CI patients. Speech perception scores in noise were significantly better in the DACI group. In summary, a DACI system seems to provide an effective treatment option as the acoustic component can be preserved in patients with advanced otosclerosis.

Measurement and Analysis of Feedback and Nonlinearities for the Codacs Direct Acoustic Cochlear Implant

Acoustic feedback is a very common problem in hearing instruments. Not only does it occur in common behind-the-ear or in-the-ear hearing aids, it also affects bone conduction implants, middle ear implants, and more recent devices, such as the direct acoustic cochlear implant (DACI). In this paper, we present the data and analysis relating to the feedback path characterization of the Cochlear™ Codacs™ DACI, performed on fresh frozen cadaver heads in four different measurement sessions. The general objectives were the following: 1) To measure and analyze the feedback path of the system and check for possible specimen-dependent variabilities; 2) To assess whether this feedback path is affected by an incorrect implantation; 3) To check for nonlinear behavior; and 4) To determine differences between tissular and airborne feedback. The data analysis reveals that the feedback seems to be dependent on the specific head morphology of the implanted specimen, and that an incorrect implantation might strongly affect the feedback path; additionally, the analysis reveals that some nonlinear behavior at high stimulus levels can be expected and, finally, that the feedback path is characterized by a tissular feedback component with a rather different frequency content compared to the airborne feedback component.

Direct Acoustic Stimulation at the Lateral Canal: An Alternative Route to the Inner Ear?

Severe to profound mixed hearing loss is associated with hearing rehabilitation difficulties. Recently, promising results for speech understanding were obtained with a direct acoustic cochlear implant (DACI). The surgical implantation of a DACI with standard coupling through a stapedotomy can however be regarded as challenging. Therefore, in this experimental study, the feasibility of direct acoustic stimulation was investigated at an anatomically and surgically more accessible inner ear site. DACI stimulation of the intact, blue-lined and opened lateral semicircular canal (LC) was investigated and compared with standard oval window (OW) coupling. Additionally, stapes footplate fixation was induced. Round window (RW) velocity, as a measure of the performance of the device and its coupling efficiency, was determined in fresh-frozen human cadaver heads. Using single point laser Doppler vibrometry, RW velocity could reliably be measured in low and middle frequency range, and equivalent sound pressure level (LE) output was calculated. Results for the different conditions obtained in five heads were analyzed in subsequent frequency ranges. Comparing the difference in RW membrane velocity showed higher LE in the LC opened condition [mean: 103 equivalent dB SPL], than in LC intact or blue-lined conditions [63 and 74 equivalent dB SPL, respectively]. No difference was observed between the LC opened and the standard OW condition. Inducing stapes fixation, however, led to a difference in the low frequency range of LE compared to LC opened. In conclusion, this feasibility study showed promising results for direct acoustic stimulation at this specific anatomically and surgically more accessible inner ear site. Future studies are needed to address the impact of LC stimulation on cochlear micromechanics and on the vestibular system like dizziness and risks of hearing loss.

A New Surgical Approach for Direct Acoustic Cochlear Implant: A Temporal Bone Study.

ObjectivesThe direct acoustic cochlear implant (DACI) is among the latest developments in the field of implantable acoustic prostheses. The surgical procedure requires a mastoidectomy and a posterior-inferior tympanotomy, with access to the facial recess at the level of the oval window, in a complex and lengthy surgical approach. Here, we report a new and considerably shorter surgical approach.MethodsThe new approach involves positioning of artificial incus above the oval window through the superior-anterior tympanotomy. We performed DACI placement in temporal bone specimens (n=5) to assess the feasibility of the new approach.ResultsThe average time for the DACI implant in the temporal bones was only 112 minutes (range, 94 to 142 minutes) and there was little clinical risk associated with the procedure. Access was easy and drilling was minimal.ConclusionOur approach simplified the surgical procedure and consequently reduced the time required for DACI placement.

A Comparative Study on Speech in Noise Understanding with a Direct Acoustic Cochlear Implant in Subjects with Severe to Profound Mixed Hearing Loss

The aim of this study was to investigate the efficacy of a direct acoustic cochlear implant (DACI) for speech understanding in noise in patients suffering from severe to profound mixed hearing loss (MHL) due to various etiologies compared to the preoperative best-aided condition. The study was performed at five tertiary referral centers in Europe (Belgium, Germany, Poland and Spain). Nineteen adult subjects with severe to profound MHL due to (advanced) otosclerosis, ear canal fibrosis, chronic otitis media, tympanosclerosis or previous cholesteatoma were implanted with a DACI (Codacs™ Investigational Device) combined with a conventional stapes prosthesis. Unaided and aided speech reception scores in quiet and in noise, preoperative and postoperative air and bone conduction thresholds and aided and unaided sound field thresholds were measured prospectively during the study. Subjective benefit analysis was determined through the Abbreviated Profile of Hearing Aid Benefit questionnaire. Quality of life was measured by the Health Utilities Index. All subjects were fitted preoperatively with hearing aids and/or a bone conduction implant on a headband before DACI implantation. This allows direct comparison between different hearing rehabilitation solutions. The mean speech reception threshold in noise improved significantly by 7.9 dB signal-to-noise ratio (SNR) after activation of the DACI compared to the preoperative best-aided condition. For all 19 subjects, a mean postoperative aided speech reception threshold of 2.6 dB SNR (standard deviation: 8.3 dB) was measured. On average, no significant shift in the bone conduction thresholds was noted 4-5 months after implantation. A mean sound field threshold improvement of 46 and 16 dB was measured compared to the preoperative unaided and best-aided condition, respectively. Speech perception tests in quiet showed a mean improvement of the word recognition scores by 65 and 48% at 65 dB SPL compared to the preoperative unaided and best-aided condition, respectively. In summary, DACI provides an effective improvement of the speech perception in noise compared to the best-aided condition in subjects suffering from severe to profound MHL.

Multicenter Study With a Direct Acoustic Cochlear Implant

To confirm the clinical efficacy and safety of a direct acoustic cochlear implant. Prospective multicenter study. The study was performed at 3 university hospitals in Europe (Germany, The Netherlands, and Switzerland). Fifteen patients with severe-to-profound mixed hearing loss because of otosclerosis or previous failed stapes surgery. Implantation with a Codacs direct acoustic cochlear implant investigational device (ID) combined with a stapedotomy with a conventional stapes prosthesis Preoperative and postoperative (3 months after activation of the investigational direct acoustic cochlear implant) audiometric evaluation measuring conventional pure tone and speech audiometry, tympanometry, aided thresholds in sound field and hearing difficulty by the Abbreviated Profile of Hearing Aid Benefit questionnaire. The preoperative and postoperative air and bone conduction thresholds did not change significantly by the implantation with the investigational Direct Acoustic Cochlear Implant. The mean sound field thresholds (0.25-8 kHz) improved significantly by 48 dB. The word recognition scores (WRS) at 50, 65, and 80 dB SPL improved significantly by 30.4%, 75%, and 78.2%, respectively, after implantation with the investigational direct acoustic cochlear implant compared with the preoperative unaided condition. The difficulty in hearing, measured by the Abbreviated Profile of Hearing Aid Benefit, decreased by 27% after implantation with the investigational direct acoustic cochlear implant. Patients with moderate-to-severe mixed hearing loss because of otosclerosis can benefit substantially using the Codacs investigational device.

Assessment of a Direct Acoustic Cochlear Stimulator

This study aimed to assess the functional results of a new, active, acoustic-mechanical hearing implant, the Direct Acoustic Cochlear Stimulation Partial Implant (DACS PI), in a preclinical study. The DACS PI is an electromagnetic device fixed to the mastoid by screws and coupled to a standard stapes prosthesis by an artificial incus (AI). The function of the DACS PI-aided reconstruction was assessed by determining: (1) the maximum equivalent sound pressure level (SPL) of the implant, which was obtained from measurements of the volume displacement at the round window in normal and implanted ears, and (2) the quality at the coupling interface between the AI of the DACS and the stapes prosthesis, which was quantified from measurements of relative motions between the AI and the prosthesis. Both measurements were performed with fresh temporal bones using a scanning laser Doppler interferometry system. The expected maximum equivalent SPL with a typical driving voltage of 0.3 V was about 115–125 dB SPL up to 1.5 kHz in reconstruction with the DACS PI, and decreased with a roll-off slope of about 65 dB/decade, reaching 90 dB SPL at 8 kHz. The large roll-off relative to a normal ear was presumed to be a relatively high inductive impedance of the coil of the DACS PI actuator at higher frequencies. Good coupling quality between the AI and the prosthesis was achieved below the resonance (∼1.5 kHz) of the DACS PI for all tested stapes prostheses. Above the resonance, the SMart Piston, which is composed of a shape-memory alloy, had the best coupling quality.