The objective of this health technology policy assessment was to determine the effectiveness and cost-effectiveness of bone-anchored hearing aid (BAHA) in improving the hearing of people with conduction or mixed hearing loss.
The (BAHA) is a bone conduction hearing device that includes a titanium fixture permanently implanted into the mastoid bone of the skull and an external percutaneous sound processor. The sound processor is attached to the fixture by means of a skin penetrating abutment. Because the device bypasses the middle ear and directly stimulates the cochlea, it has been recommended for individuals with conduction hearing loss or discharging middle ear infection.
The titanium implant is expected to last a lifetime while the external sound processor is expected to last 5 years. The total initial device cost is approximately $5,300 and the external sound processor costs approximately $3,500.
Review of BAHA by the Medical Advisory Secretariat
The Medical Advisory Secretariat’s review is a descriptive synthesis of findings from 36 research articles published between January 1990 and May 2002.
Summary of Findings
No randomized controlled studies were found. The evidence was derived from level 4 case series with relative small sample sizes (ranging from 30-188). The majority of the studies have follow-up periods of eight years or longer. All except one study were based on monaural BAHA implant on the side with the best bone conduction threshold.
Level 4 evidence showed that BAHA has been be implanted safely in adults and children with success rates of 90% or higher in most studies. No mortality or life threatening morbidity has been reported. Revision rates for tissue reduction or resiting were generally under 10% for adults but have been reported to be as high as 25% in pediatric studies.
Adverse skin reaction around the skin penetration site was the most common complication reported. Most of these conditions were successfully treated with antibiotics, and only 1% to 2% required surgical revision. Less than 1% required removal of the fixture.
Other complications included failure to osseointegrate and loss of fixture and/or abutment due to trauma or infection.
Studies showed that BAHAs were implanted in people who have conduction or mixed hearing loss, congenital atresia or suppurative otitis media who were not candidates for surgical repair, and who cannot use conventional bone conduction hearing aids. The need for BAHA is not age- related. Objective audiometric measures and subjective patient satisfaction surveys showed that BAHA significantly improved the unaided and aided free field and sound field thresholds as well as speech discrimination in quiet and in noise for former users of conventional bone conduction hearing aids. The outcomes were ambiguous for former users of air conduction hearing aids.
BAHA has been shown to reduce the frequency of ear infection and reduce the discharge particularly among patients with suppurative otitis media.
Patients have reported that BAHA improved their quality of life. Reported benefits were improved speech intelligibility, better sound comfort, less pressure on the head, less skin irritation, greater cosmetic acceptance and increase in confidence. Main reported shortcomings were wind noise, feedback and difficulty in using the telephone.
Experts and the BAHA manufacturer recommended that recipients of a BAHA implant be at least 5 years old. Challenges associated with the implantation of BAHA in pediatric patients include thin bone, soft bone, higher rates of fixture loss due to trauma, psychological problems, and higher revision rates due to rapid bone growth. The overall outcomes are comparable to adult BAHA. The benefits of pediatric BAHA (e.g. on speech development) appear to outweigh the disadvantages.
Screening according to strict eligibility criteria, preoperative counselling, close monitoring by a physician with BAHA expertise and on-going follow-up were identified as critical factors for long-term implant survival. Examples of eligibility criteria were provided.
No literature on cost-effectiveness of BAHA was found.